Epidemiology of Non- Invasive Mechanical Ventilation in Argentina: a Multicenter Observational Study
NCT ID: NCT06837402
Last Updated: 2025-05-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Total Enrollment
246 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-05-01
Study Completion Date
2026-04-01
Brief Summary
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Introduction Non-invasive mechanical ventilation (NIMV) is a fundamental strategy in the management of acute respiratory failure, preventing intubation and reducing complications. However, the epidemiology of its use in Argentina is not well understood, motivating this study.
Justification Unequal access to ICU resources in Argentina affects the quality of care. This study aims to describe the implementation, effectiveness, and outcomes of NIMV across different regions of the country to improve clinical decision-making and healthcare policies.
Objectives
* Primary: Analyze the survival of ICU patients receiving NIMV.
* Secondary: Evaluate success/failure factors, regional disparities in resource availability, the impact of healthcare staff training, comparison between public and private sectors, and establish a national database.
Methods Study Design Observational, multicenter, prospective, and analytical study. Both public and private hospitals in Argentina will be included. Data will be collected over seven months, with patient follow-up until discharge or death.
Study Population Adult patients (\>18 years) admitted to the ICU requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation.
Inclusion Criteria
* Age \>18 years.
* Use of NIMV in the ICU for respiratory failure or during weaning.
* Signed informed consent.
Exclusion Criteria
* Patients using home NIMV without exacerbation.
* Patients without acute respiratory impairment.
Data Collection and Management
* Data will be recorded using an electronic form in RedCap®, with restricted access.
* Confidentiality will be ensured through alphanumeric coding.
* A monitoring committee will supervise data quality.
Statistical Analysis
* Continuous variables: Mean and standard deviation or median and interquartile range.
* Comparisons: Student's t-test, Mann-Whitney U test, Chi² test, or Fisher's exact test.
* Multivariate models: Logistic regression and Kaplan-Meier survival analysis.
Bias Control and Data Quality Strategies will be implemented to minimize selection, information, and investigator bias. Data will be periodically reviewed by the monitoring committee.
Study Feasibility The study is supported by the British Hospital of Buenos Aires and the Argentine Society of Intensive Care Medicine, ensuring its viability.
Ethical Considerations The study will comply with national and international health research regulations, ensuring participant confidentiality.
Publication and Funding The study will be funded by the Argentine Society of Intensive Care Medicine, with no external financial support. Authorship in publications will depend on the number of patients included per center.
Conclusion This study aims to generate key information on NIMV use in Argentina, optimizing its application and improving ICU care nationwide.
Justification Unequal access to ICU resources in Argentina affects the quality of care. This study aims to describe the implementation, effectiveness, and outcomes of NIMV across different regions of the country to improve clinical decision-making and healthcare policies.
Objectives
* Primary: Analyze the survival of ICU patients receiving NIMV.
* Secondary: Evaluate success/failure factors, regional disparities in resource availability, the impact of healthcare staff training, comparison between public and private sectors, and establish a national database.
Methods Study Design Observational, multicenter, prospective, and analytical study. Both public and private hospitals in Argentina will be included. Data will be collected over seven months, with patient follow-up until discharge or death.
Study Population Adult patients (\>18 years) admitted to the ICU requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation.
Inclusion Criteria
* Age \>18 years.
* Use of NIMV in the ICU for respiratory failure or during weaning.
* Signed informed consent.
Exclusion Criteria
* Patients using home NIMV without exacerbation.
* Patients without acute respiratory impairment.
Data Collection and Management
* Data will be recorded using an electronic form in RedCap®, with restricted access.
* Confidentiality will be ensured through alphanumeric coding.
* A monitoring committee will supervise data quality.
Statistical Analysis
* Continuous variables: Mean and standard deviation or median and interquartile range.
* Comparisons: Student's t-test, Mann-Whitney U test, Chi² test, or Fisher's exact test.
* Multivariate models: Logistic regression and Kaplan-Meier survival analysis.
Bias Control and Data Quality Strategies will be implemented to minimize selection, information, and investigator bias. Data will be periodically reviewed by the monitoring committee.
Study Feasibility The study is supported by the British Hospital of Buenos Aires and the Argentine Society of Intensive Care Medicine, ensuring its viability.
Ethical Considerations The study will comply with national and international health research regulations, ensuring participant confidentiality.
Publication and Funding The study will be funded by the Argentine Society of Intensive Care Medicine, with no external financial support. Authorship in publications will depend on the number of patients included per center.
Conclusion This study aims to generate key information on NIMV use in Argentina, optimizing its application and improving ICU care nationwide.
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Detailed Description
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Background and Rationale Non-invasive mechanical ventilation (NIMV) has become a crucial treatment in managing acute respiratory failure, preventing the need for endotracheal intubation and its associated complications. Numerous studies have demonstrated that timely and appropriate NIMV use reduces mortality, decreases the incidence of ventilator-associated pneumonia, and minimizes hospital length of stay. However, the epidemiology of NIMV use in Argentina remains largely undocumented, particularly regarding regional disparities in access, implementation, and patient outcomes.
This multicenter observational study aims to fill this knowledge gap by analyzing NIMV utilization in intensive care units (ICUs) across Argentina. The study will evaluate patient characteristics, clinical outcomes, and factors influencing NIMV success or failure. Additionally, it will assess the impact of healthcare staff training and the differences between public and private healthcare settings.
Study Objectives Primary Objective
\- Analyze the survival rates of ICU patients receiving NIMV.
Secondary Objectives
* Identify factors associated with NIMV success or failure, including the need for intubation.
* Describe demographic and clinical characteristics of patients requiring NIMV.
* Compare mortality rates between successful and failed NIMV cases.
* Evaluate regional disparities in resource availability and NIMV usage.
* Analyze the impact of staff training levels on patient outcomes.
* Compare NIMV practices between public and private hospitals.
* Establish a national database to facilitate ongoing assessment of NIMV in Argentina.
Study Design This is a prospective, multicenter, observational, and analytical study that will collect data from ICUs in both public and private hospitals across different regions of Argentina. The study will be conducted over seven months to capture seasonal variations in respiratory diseases. All enrolled patients will be followed until discharge or death.
Population and Setting The study will include adult patients (≥18 years old) admitted to ICUs and requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation (IMV). Participating hospitals must have the capacity to provide NIMV and record detailed patient data.
Eligibility Criteria
Inclusion Criteria:
* Patients ≥18 years old requiring NIMV in ICU for acute respiratory failure (hypoxemic, hypercapnic, or mixed) or as part of IMV weaning.
* Patients receiving palliative NIMV or as part of end-of-life care.
* Patients requiring increased duration or level of NIMV support due to worsening condition.
* Signed informed consent from the patient or a legal representative.
Exclusion Criteria:
* Patients using home NIMV for chronic respiratory conditions (e.g., COPD, neuromuscular diseases, obesity hypoventilation syndrome) without acute respiratory deterioration.
* Patients without acute respiratory distress at ICU admission.
Data Collection and Variables Data Management System
* Data will be collected using an electronic form in RedCap® with restricted access.
* Each participating ICU will have a designated site coordinator responsible for data collection and entry.
* To ensure data accuracy, a monitoring committee will review a random 5% sample of enrolled patients.
Key Variables Baseline Data
* Demographics: Age, sex, weight, height.
* ICU admission data: Date of hospital and ICU admission.
* Charlson Comorbidity Index and APACHE II score at ICU admission.
* Previous NIMV or oxygen therapy use (home or pre-ICU).
NIMV Implementation
* Date of NIMV initiation in ICU.
* Initial arterial blood gas (ABG) values: pH, PaCO₂, PaO₂, SaO₂, FiO₂.
* Primary reason for NIMV: COPD exacerbation, asthma, pneumonia, ARDS, post-operative respiratory failure, cardiogenic pulmonary edema, neuromuscular disease, etc.
* Ventilator settings: Mode (e.g., PSV, PCV), inspiratory pressure, PEEP, FiO₂, respiratory rate, tidal volume.
* Interface used: Helmet, oronasal mask, nasal mask, mouthpiece.
* Humidification use (active/passive).
* Adjunct therapies: Sedation, analgesia, high-flow nasal oxygen (HFNO).
Monitoring and Outcomes
* Daily ABG values and ventilator settings during NIMV use.
* Signs of respiratory distress: Tachypnea, accessory muscle use, paradoxical breathing.
* Complications: Facial pressure ulcers, barotrauma, pneumonia, gastric distension.
* Failure criteria: Need for intubation or death during NIMV.
* Length of NIMV use and ICU/hospital stay duration.
* Mortality at day 28 and at hospital discharge.
* Final disposition: Discharge to home, rehabilitation center, or another hospital unit.
Statistical Analysis
* Descriptive statistics:
* Continuous variables: Mean ± SD or median (IQR).
* Categorical variables: Frequency and percentages.
* Comparative analysis:
* Student's t-test or Mann-Whitney U test for continuous variables.
* Chi-square test or Fisher's exact test for categorical variables.
* Multivariate analysis:
* Logistic regression to identify predictors of NIMV failure.
* Kaplan-Meier survival analysis and Cox proportional hazards model to assess survival outcomes.
* Missing data handling: Patients with \>10% missing key variables will be excluded from the final analysis.
* Software: All statistical analyses will be performed using R 4.3.3, with ggplot2 for visualizations and Survival package for survival analysis.
Bias Control and Quality Assurance
* Selection bias: Consecutive patient recruitment to minimize inclusion bias.
* Information bias: Standardized electronic data collection with training for investigators.
* Investigator bias: Use of predefined diagnostic criteria and cut-off values.
Ethical Considerations
* The study will comply with international research ethics standards (Helsinki Declaration, ICH-GCP).
* Data will be anonymized and securely stored, following Argentina's Data Protection Law (25.326/00).
* Ethical approval will be obtained from the Ethics Committee of the British Hospital of Buenos Aires and participating institutions.
Study Feasibility
* The study will be coordinated by the British Hospital of Buenos Aires with support from the Argentine Society of Intensive Care Medicine (SATI).
* No external funding; the study is supported by SATI.
* Participating centers will be invited via SATI networks and social media, with a structured training program to ensure compliance with data collection protocols.
Conclusion This study will provide essential insights into NIMV epidemiology in Argentina, helping to optimize its implementation and improve ICU care nationwide. By identifying key predictors of success or failure, the study will contribute to evidence-based clinical practice and inform national health policies regarding ventilatory support strategies.
This multicenter observational study aims to fill this knowledge gap by analyzing NIMV utilization in intensive care units (ICUs) across Argentina. The study will evaluate patient characteristics, clinical outcomes, and factors influencing NIMV success or failure. Additionally, it will assess the impact of healthcare staff training and the differences between public and private healthcare settings.
Study Objectives Primary Objective
\- Analyze the survival rates of ICU patients receiving NIMV.
Secondary Objectives
* Identify factors associated with NIMV success or failure, including the need for intubation.
* Describe demographic and clinical characteristics of patients requiring NIMV.
* Compare mortality rates between successful and failed NIMV cases.
* Evaluate regional disparities in resource availability and NIMV usage.
* Analyze the impact of staff training levels on patient outcomes.
* Compare NIMV practices between public and private hospitals.
* Establish a national database to facilitate ongoing assessment of NIMV in Argentina.
Study Design This is a prospective, multicenter, observational, and analytical study that will collect data from ICUs in both public and private hospitals across different regions of Argentina. The study will be conducted over seven months to capture seasonal variations in respiratory diseases. All enrolled patients will be followed until discharge or death.
Population and Setting The study will include adult patients (≥18 years old) admitted to ICUs and requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation (IMV). Participating hospitals must have the capacity to provide NIMV and record detailed patient data.
Eligibility Criteria
Inclusion Criteria:
* Patients ≥18 years old requiring NIMV in ICU for acute respiratory failure (hypoxemic, hypercapnic, or mixed) or as part of IMV weaning.
* Patients receiving palliative NIMV or as part of end-of-life care.
* Patients requiring increased duration or level of NIMV support due to worsening condition.
* Signed informed consent from the patient or a legal representative.
Exclusion Criteria:
* Patients using home NIMV for chronic respiratory conditions (e.g., COPD, neuromuscular diseases, obesity hypoventilation syndrome) without acute respiratory deterioration.
* Patients without acute respiratory distress at ICU admission.
Data Collection and Variables Data Management System
* Data will be collected using an electronic form in RedCap® with restricted access.
* Each participating ICU will have a designated site coordinator responsible for data collection and entry.
* To ensure data accuracy, a monitoring committee will review a random 5% sample of enrolled patients.
Key Variables Baseline Data
* Demographics: Age, sex, weight, height.
* ICU admission data: Date of hospital and ICU admission.
* Charlson Comorbidity Index and APACHE II score at ICU admission.
* Previous NIMV or oxygen therapy use (home or pre-ICU).
NIMV Implementation
* Date of NIMV initiation in ICU.
* Initial arterial blood gas (ABG) values: pH, PaCO₂, PaO₂, SaO₂, FiO₂.
* Primary reason for NIMV: COPD exacerbation, asthma, pneumonia, ARDS, post-operative respiratory failure, cardiogenic pulmonary edema, neuromuscular disease, etc.
* Ventilator settings: Mode (e.g., PSV, PCV), inspiratory pressure, PEEP, FiO₂, respiratory rate, tidal volume.
* Interface used: Helmet, oronasal mask, nasal mask, mouthpiece.
* Humidification use (active/passive).
* Adjunct therapies: Sedation, analgesia, high-flow nasal oxygen (HFNO).
Monitoring and Outcomes
* Daily ABG values and ventilator settings during NIMV use.
* Signs of respiratory distress: Tachypnea, accessory muscle use, paradoxical breathing.
* Complications: Facial pressure ulcers, barotrauma, pneumonia, gastric distension.
* Failure criteria: Need for intubation or death during NIMV.
* Length of NIMV use and ICU/hospital stay duration.
* Mortality at day 28 and at hospital discharge.
* Final disposition: Discharge to home, rehabilitation center, or another hospital unit.
Statistical Analysis
* Descriptive statistics:
* Continuous variables: Mean ± SD or median (IQR).
* Categorical variables: Frequency and percentages.
* Comparative analysis:
* Student's t-test or Mann-Whitney U test for continuous variables.
* Chi-square test or Fisher's exact test for categorical variables.
* Multivariate analysis:
* Logistic regression to identify predictors of NIMV failure.
* Kaplan-Meier survival analysis and Cox proportional hazards model to assess survival outcomes.
* Missing data handling: Patients with \>10% missing key variables will be excluded from the final analysis.
* Software: All statistical analyses will be performed using R 4.3.3, with ggplot2 for visualizations and Survival package for survival analysis.
Bias Control and Quality Assurance
* Selection bias: Consecutive patient recruitment to minimize inclusion bias.
* Information bias: Standardized electronic data collection with training for investigators.
* Investigator bias: Use of predefined diagnostic criteria and cut-off values.
Ethical Considerations
* The study will comply with international research ethics standards (Helsinki Declaration, ICH-GCP).
* Data will be anonymized and securely stored, following Argentina's Data Protection Law (25.326/00).
* Ethical approval will be obtained from the Ethics Committee of the British Hospital of Buenos Aires and participating institutions.
Study Feasibility
* The study will be coordinated by the British Hospital of Buenos Aires with support from the Argentine Society of Intensive Care Medicine (SATI).
* No external funding; the study is supported by SATI.
* Participating centers will be invited via SATI networks and social media, with a structured training program to ensure compliance with data collection protocols.
Conclusion This study will provide essential insights into NIMV epidemiology in Argentina, helping to optimize its implementation and improve ICU care nationwide. By identifying key predictors of success or failure, the study will contribute to evidence-based clinical practice and inform national health policies regarding ventilatory support strategies.
Conditions
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Respiration, Artificial
Noninvasive Ventilation
Intensive Care Units
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years of age.
* Requirement of NIMV in ICU due to acute respiratory failure (hypoxemic or hypercapnic or mixed) or as part of the process of weaning from mechanical ventilation.
* Patients who receive NIMV as a palliative or as part of end-of-life care.
* Patients as a routine treatment who require an increase in the time of use, or the level of support, or both due to increased demand.
* Informed consent signed by the patient or his/her legal representative in the event that the patient is incapacitated.
* Requirement of NIMV in ICU due to acute respiratory failure (hypoxemic or hypercapnic or mixed) or as part of the process of weaning from mechanical ventilation.
* Patients who receive NIMV as a palliative or as part of end-of-life care.
* Patients as a routine treatment who require an increase in the time of use, or the level of support, or both due to increased demand.
* Informed consent signed by the patient or his/her legal representative in the event that the patient is incapacitated.
Exclusion Criteria
* Patients admitted to the ICU with NIV as standard treatment for chronic lung disease, neuromuscular disease, obstructive sleep apnea-hypopnea syndrome, or obesity hypoventilation syndrome without additional respiratory compromise.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Argentinian Intensive Care Society
OTHER
Sponsor Role
lead
Responsible Party
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Gustavo Plotnikow
Respiratory Therapist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Gustavo Plotnikow, RT
Role: PRINCIPAL_INVESTIGATOR
Hospital Británico
Locations
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Hospital Británico de Buenos Aires
CABA, Buenos Aires, Argentina
Site Status
Countries
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Argentina
References
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Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
Reference Type
BACKGROUND
Chawla R, Dixit SB, Zirpe KG, Chaudhry D, Khilnani GC, Mehta Y, Khatib KI, Jagiasi BG, Chanchalani G, Mishra RC, Samavedam S, Govil D, Gupta S, Prayag S, Ramasubban S, Dobariya J, Marwah V, Sehgal I, Jog SA, Kulkarni AP. ISCCM Guidelines for the Use of Non-invasive Ventilation in Acute Respiratory Failure in Adult ICUs. Indian J Crit Care Med. 2020 Jan;24(Suppl 1):S61-S81. doi: 10.5005/jp-journals-10071-G23186.
Reference Type
BACKGROUND
Fujishima S. Guideline-based management of acute respiratory failure and acute respiratory distress syndrome. J Intensive Care. 2023 Mar 10;11(1):10. doi: 10.1186/s40560-023-00658-3.
Reference Type
BACKGROUND
Nava S, Navalesi P, Conti G. Time of non-invasive ventilation. Intensive Care Med. 2006 Mar;32(3):361-70. doi: 10.1007/s00134-005-0050-0. Epub 2006 Feb 14.
Reference Type
BACKGROUND
Klefti G, Hill AT. The benefits of non-invasive ventilation for Community-Acquired Pneumonia: A meta-analysis. QJM. 2020 Mar 30:hcaa106. doi: 10.1093/qjmed/hcaa106. Online ahead of print.
Reference Type
BACKGROUND
Burns KEA, Stevenson J, Laird M, Adhikari NKJ, Li Y, Lu C, He X, Wang W, Liang Z, Chen L, Zhang H, Friedrich JO. Non-invasive ventilation versus invasive weaning in critically ill adults: a systematic review and meta-analysis. Thorax. 2022 Aug;77(8):752-761. doi: 10.1136/thoraxjnl-2021-216993. Epub 2021 Oct 29.
Reference Type
BACKGROUND
Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Jul 13;7(7):CD004104. doi: 10.1002/14651858.CD004104.pub4.
Reference Type
BACKGROUND
Farhan H, Moreno-Duarte I, Latronico N, Zafonte R, Eikermann M. Acquired Muscle Weakness in the Surgical Intensive Care Unit: Nosology, Epidemiology, Diagnosis, and Prevention. Anesthesiology. 2016 Jan;124(1):207-34. doi: 10.1097/ALN.0000000000000874.
Reference Type
BACKGROUND
Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
Reference Type
BACKGROUND
Dowdy DW, Eid MP, Sedrakyan A, Mendez-Tellez PA, Pronovost PJ, Herridge MS, Needham DM. Quality of life in adult survivors of critical illness: a systematic review of the literature. Intensive Care Med. 2005 May;31(5):611-20. doi: 10.1007/s00134-005-2592-6. Epub 2005 Apr 1.
Reference Type
BACKGROUND
Combes A, Costa MA, Trouillet JL, Baudot J, Mokhtari M, Gibert C, Chastre J. Morbidity, mortality, and quality-of-life outcomes of patients requiring >or=14 days of mechanical ventilation. Crit Care Med. 2003 May;31(5):1373-81. doi: 10.1097/01.CCM.0000065188.87029.C3.
Reference Type
BACKGROUND
Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. doi: 10.1007/s00134-003-2004-8. Epub 2003 Sep 5.
Reference Type
BACKGROUND
Jubran A, Lawm G, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Post-traumatic stress disorder after weaning from prolonged mechanical ventilation. Intensive Care Med. 2010 Dec;36(12):2030-7. doi: 10.1007/s00134-010-1972-8. Epub 2010 Jul 27.
Reference Type
BACKGROUND
Jubran A, Lawm G, Kelly J, Duffner LA, Gungor G, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Depressive disorders during weaning from prolonged mechanical ventilation. Intensive Care Med. 2010 May;36(5):828-35. doi: 10.1007/s00134-010-1842-4. Epub 2010 Mar 16.
Reference Type
BACKGROUND
Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
Reference Type
BACKGROUND
Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
Reference Type
BACKGROUND
MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
Reference Type
BACKGROUND
Nava S, Ambrosino N, Rubini F, Fracchia C, Rampulla C, Torri G, Calderini E. Effect of nasal pressure support ventilation and external PEEP on diaphragmatic activity in patients with severe stable COPD. Chest. 1993 Jan;103(1):143-50. doi: 10.1378/chest.103.1.143.
Reference Type
BACKGROUND
Appendini L, Patessio A, Zanaboni S, Carone M, Gukov B, Donner CF, Rossi A. Physiologic effects of positive end-expiratory pressure and mask pressure support during exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1994 May;149(5):1069-76. doi: 10.1164/ajrccm.149.5.8173743.
Reference Type
BACKGROUND
Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001 Feb;163(2):540-77. doi: 10.1164/ajrccm.163.2.9906116. No abstract available.
Reference Type
BACKGROUND
Rathgeber J, Schorn B, Falk V, Kazmaier S, Spiegel T, Burchardi H. The influence of controlled mandatory ventilation (CMV), intermittent mandatory ventilation (IMV) and biphasic intermittent positive airway pressure (BIPAP) on duration of intubation and consumption of analgesics and sedatives. A prospective analysis in 596 patients following adult cardiac surgery. Eur J Anaesthesiol. 1997 Nov;14(6):576-82. doi: 10.1046/j.1365-2346.1994.00178.x.
Reference Type
BACKGROUND
Criner GJ, Tzouanakis A, Kreimer DT. Overview of improving tolerance of long-term mechanical ventilation. Crit Care Clin. 1994 Oct;10(4):845-66.
Reference Type
BACKGROUND
Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
Reference Type
BACKGROUND
Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
Reference Type
BACKGROUND
Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.
Reference Type
BACKGROUND
Estenssoro E, Plotnikow G, Loudet CI, Rios FG, Kanoore Edul VS, Andrian M, Romero I, Sagardia J, Bezzi M, Mandich V, Groer C, Torres S, Orlandi C, Rubatto Birri PN, Valenti MF, Cunto E, Saenz MG, Tiribelli N, Aphalo V, Betttini L, Reina R, Dubin A; Grupo de investigadores del estudio SATICOVID-19. [Structural capacity, technological human resources and mechanical ventilation requirements in 58 intensive care units in Argentina during the SARS-CoV-2 pandemic. A SATICOVID-19 Study]. Medicina (B Aires). 2022;82(1):35-46. Spanish.
Reference Type
BACKGROUND
Plotnikow GA, Gogniat E, Accoce M, Navarro E, Dorado JH; EpVAr study group. Epidemiology of mechanical ventilation in Argentina. The EpVAr multicenter observational study. Med Intensiva (Engl Ed). 2022 Jul;46(7):372-382. doi: 10.1016/j.medine.2022.05.002. Epub 2022 May 31.
Reference Type
BACKGROUND
Dorado JH, Navarro E, Plotnikow GA, Gogniat E, Accoce M; EpVAr Study Group. Epidemiology of Weaning From Invasive Mechanical Ventilation in Subjects With COVID-19. Respir Care. 2023 Jan;68(1):101-109. doi: 10.4187/respcare.09925. Epub 2022 Nov 15.
Reference Type
BACKGROUND
R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. R Core Team (2017). [cited 21 Dec 2024]. URL: https://www.r-project.org/
Reference Type
BACKGROUND
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Reference Type
BACKGROUND
Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi.2008.01.006. Epub 2008 Jul 10.
Reference Type
BACKGROUND
Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
Reference Type
BACKGROUND
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
Reference Type
BACKGROUND
Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.
Reference Type
BACKGROUND
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Reference Type
BACKGROUND
Estenssoro E, Gonzalez I, Plotnikow GA. Post-pandemic acute respiratory distress syndrome: A New Global Definition with extension to lower-resource regions. Med Intensiva (Engl Ed). 2024 May;48(5):272-281. doi: 10.1016/j.medine.2024.01.011. Epub 2024 Apr 20.
Reference Type
BACKGROUND
Toro AC, Escobar LM, Franco JG, Diaz-Gomez JL, Munoz JF, Molina F, Bejarano J, Yepes D, Navarro E, Garcia A, Ely WE, Esteban A. [Spanish version of the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit). Pilot study of validation]. Med Intensiva. 2010 Jan-Feb;34(1):14-21. doi: 10.1016/j.medin.2009.07.002. Epub 2009 Sep 30. Spanish.
Reference Type
BACKGROUND
Vicente-Herrero MT, Delgado-Bueno S, Bandrés-Moyá F, Ramírez-Iñiguez-de- la-Torre MV, Capdevilla-García L. Valoración del dolor. Revisión comparativa de escalas y cuestionarios. Revista de la Sociedad Española del Dolor 2018; 25(4): 228-236.
Reference Type
BACKGROUND
Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14770
Identifier Type: -
Identifier Source: org_study_id
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