Quality of Life and Functional Capacity in Post Intensive Care Unit
NCT ID: NCT05149430
Last Updated: 2022-02-23
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
101 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-08-01
Study Completion Date
2020-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
BACKGROUND. Staying in an intensive care unit can lead to physical and cognitive complications and post-traumatic stress. Currently, the aim is to find out the level of quality of life, functional capacity and cognitive status post intensive care unit. Describe the evolution of the quality of life, functional capacity and cognitive status of a cohort of patients admitted to the ward room after discharge from the intensive care unit, with subsequent follow-up at 3, 6 and 12 months of his discharge.
METHODS. Prospective, observational, analytical cohort study. Subjects over 18 years of age with at least 48 hours of confinement in a closed area were included. Demographic variables, quality of life, functional capacity and cognitive status were recorded. A telephone follow-up was carried out three, six and twelve months after institutional discharge. For the evaluation of the primary variables, Euroqol 5d-5L (Eq5d - Eq5d-VAS), Barthel Index and Fototest were used.
METHODS. Prospective, observational, analytical cohort study. Subjects over 18 years of age with at least 48 hours of confinement in a closed area were included. Demographic variables, quality of life, functional capacity and cognitive status were recorded. A telephone follow-up was carried out three, six and twelve months after institutional discharge. For the evaluation of the primary variables, Euroqol 5d-5L (Eq5d - Eq5d-VAS), Barthel Index and Fototest were used.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Risk Factors of Sleep Quality in Intensive Care Unit
NCT00507481
Sleep Disorders
Delirium
COMPLETED
Patients Visit Prior to Hospital Admission & Intensive Care Unit
NCT03605407
Anxiety
Depression
Intensive Care Unit Syndrome
COMPLETED
NA
Future of the Older Patients After Intensive Care Unit
NCT02849756
Intensive Care Unit Syndrome
COMPLETED
Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma
NCT02832908
Traumatic Brain Injury
UNKNOWN
NA
Predictive Outcome in Comatose Patients
NCT05321459
Coma
Heart Arrest
Cardiopulmonary Resuscitation
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Post-intensive Care Syndrome
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observational Quality of life and functional capacity
Observational Quality of life and functional capacity
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All patients over 18 years old
* At least 48 hours in the ICU
* Who subsequently entered the Clinical Ward Room
* Who signed the informed consent
* At least 48 hours in the ICU
* Who subsequently entered the Clinical Ward Room
* Who signed the informed consent
Exclusion Criteria
* Those patients who received invasive mechanical ventilation in the last 6 months
* Who had been admitted to an ICU in the last 6 months
* Patients who cannot answer the questionnaires on their own or who do not have relatives to answer them
* Patients with progressive degenerative neurological pathology.
* Patients diagnosed with cancer with a life expectancy of less than 12 months according to the criteria of the oncologist.
* Who had been admitted to an ICU in the last 6 months
* Patients who cannot answer the questionnaires on their own or who do not have relatives to answer them
* Patients with progressive degenerative neurological pathology.
* Patients diagnosed with cancer with a life expectancy of less than 12 months according to the criteria of the oncologist.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cagide Sabrina
UNKNOWN
Sponsor Role
collaborator
Di giorgio Victoria
UNKNOWN
Sponsor Role
collaborator
Villalba Dario
UNKNOWN
Sponsor Role
collaborator
Accoce Matias
UNKNOWN
Sponsor Role
collaborator
Sanatorio Anchorena San Martin
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matias Bertozzi
Respiratory Therapy
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Matias Bertozzi
Buenos Aires, , Argentina
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Argentina
References
Explore related publications, articles, or registry entries linked to this study.
Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
Reference Type
BACKGROUND
Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
Reference Type
BACKGROUND
Williams TA, Dobb GJ, Finn JC, Knuiman MW, Geelhoed E, Lee KY, Webb SA. Determinants of long-term survival after intensive care. Crit Care Med. 2008 May;36(5):1523-30. doi: 10.1097/CCM.0b013e318170a405.
Reference Type
BACKGROUND
Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.
Reference Type
BACKGROUND
Dinglas VD, Faraone LN, Needham DM. Understanding patient-important outcomes after critical illness: a synthesis of recent qualitative, empirical, and consensus-related studies. Curr Opin Crit Care. 2018 Oct;24(5):401-409. doi: 10.1097/MCC.0000000000000533.
Reference Type
BACKGROUND
Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. doi: 10.1164/rccm.201001-0024WS. Epub 2010 Mar 11.
Reference Type
BACKGROUND
Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
Reference Type
BACKGROUND
Steenbergen S, Rijkenberg S, Adonis T, Kroeze G, van Stijn I, Endeman H. Long-term treated intensive care patients outcomes: the one-year mortality rate, quality of life, health care use and long-term complications as reported by general practitioners. BMC Anesthesiol. 2015 Oct 12;15:142. doi: 10.1186/s12871-015-0121-x.
Reference Type
BACKGROUND
Rydingsward JE, Horkan CM, Mogensen KM, Quraishi SA, Amrein K, Christopher KB. Functional Status in ICU Survivors and Out of Hospital Outcomes: A Cohort Study. Crit Care Med. 2016 May;44(5):869-79. doi: 10.1097/CCM.0000000000001627.
Reference Type
BACKGROUND
Dettling-Ihnenfeldt DS, Wieske L, Horn J, Nollet F, van der Schaaf M. Functional Recovery in Patients With and Without Intensive Care Unit-Acquired Weakness. Am J Phys Med Rehabil. 2017 Apr;96(4):236-242. doi: 10.1097/PHM.0000000000000586.
Reference Type
BACKGROUND
Duarte PAD, Costa JB, Duarte ST, Taba S, Lordani CRF, Osaku EF, Costa CRLM, Miglioranza DC, Gund DP, Jorge AC. Characteristics and Outcomes of Intensive Care Unit Survivors: Experience of a Multidisciplinary Outpatient Clinic in a Teaching Hospital. Clinics (Sao Paulo). 2017 Dec;72(12):764-772. doi: 10.6061/clinics/2017(12)08.
Reference Type
BACKGROUND
Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.
Reference Type
BACKGROUND
Augustovski FA, Irazola VE, Velazquez AP, Gibbons L, Craig BM. Argentine valuation of the EQ-5D health states. Value Health. 2009 Jun;12(4):587-96. doi: 10.1111/j.1524-4733.2008.00468.x. Epub 2008 Nov 12.
Reference Type
BACKGROUND
Della Pietra GL, Savio K, Oddone E, Reggiani M, Monaco F, Leone MA. Validity and reliability of the Barthel index administered by telephone. Stroke. 2011 Jul;42(7):2077-9. doi: 10.1161/STROKEAHA.111.613521. Epub 2011 Apr 28.
Reference Type
BACKGROUND
Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.
Reference Type
BACKGROUND
Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19(1):274. doi: 10.1186/s13054-015-0993-7.
Reference Type
BACKGROUND
Diaz Ballve LP, Dargains N, Urrutia Inchaustegui JG, Bratos A, Milagros Percaz M, Bueno Ardariz C, Cagide S, Balestrieri C, Gamarra C, Paz D, Rotela E, Muller S, Bustos F, Aranda Castro R, Settembrino E. Weakness acquired in the intensive care unit. Incidence, risk factors and their association with inspiratory weakness. Observational cohort study. Rev Bras Ter Intensiva. 2017 Oct-Dec;29(4):466-475. doi: 10.5935/0103-507X.20170063. Epub 2017 Dec 7.
Reference Type
BACKGROUND
Carnero-Pardo C, Lopez-Alcalde S, Allegri RF, Russo MJ. A systematic review and meta-analysis of the diagnostic accuracy of the Phototest for cognitive impairment and dementia. Dement Neuropsychol. 2014 Apr-Jun;8(2):141-147. doi: 10.1590/S1980-57642014DN82000009.
Reference Type
BACKGROUND
Carnero-Pardo C, Saez-Zea C, De la Vega Cotarelo R, Gurpegui M; en nombre del grupo FOTOTRANS. [FOTOTRANS study: multicentre study on the validity of Fototest under clinical practice conditions]. Neurologia. 2012 Mar;27(2):68-75. doi: 10.1016/j.nrl.2011.06.001. Epub 2011 Sep 1. Spanish.
Reference Type
BACKGROUND
Sacanella E, Perez-Castejon JM, Nicolas JM, Masanes F, Navarro M, Castro P, Lopez-Soto A. Functional status and quality of life 12 months after discharge from a medical ICU in healthy elderly patients: a prospective observational study. Crit Care. 2011;15(2):R105. doi: 10.1186/cc10121. Epub 2011 Mar 28.
Reference Type
BACKGROUND
Pintado MC, Villa P, Lujan J, Trascasa M, Molina R, Gonzalez-Garcia N, de Pablo R. Mortality and functional status at one-year of follow-up in elderly patients with prolonged ICU stay. Med Intensiva. 2016 Jun-Jul;40(5):289-97. doi: 10.1016/j.medin.2015.08.002. Epub 2015 Dec 23. English, Spanish.
Reference Type
BACKGROUND
Hopkins RO, Miller RR 3rd, Rodriguez L, Spuhler V, Thomsen GE. Physical therapy on the wards after early physical activity and mobility in the intensive care unit. Phys Ther. 2012 Dec;92(12):1518-23. doi: 10.2522/ptj.20110446. Epub 2012 Apr 5.
Reference Type
BACKGROUND
Rollinson TC, Connolly B, Berlowitz DJ, Berney S. Physical activity of patients with critical illness undergoing rehabilitation in intensive care and on the acute ward: An observational cohort study. Aust Crit Care. 2022 Jul;35(4):362-368. doi: 10.1016/j.aucc.2021.06.005. Epub 2021 Aug 10.
Reference Type
BACKGROUND
Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.
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
Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.
Reference Type
BACKGROUND
Linko R, Suojaranta-Ylinen R, Karlsson S, Ruokonen E, Varpula T, Pettila V; FINNALI study investigators. One-year mortality, quality of life and predicted life-time cost-utility in critically ill patients with acute respiratory failure. Crit Care. 2010;14(2):R60. doi: 10.1186/cc8957. Epub 2010 Apr 12.
Reference Type
BACKGROUND
Eggmann S, Luder G, Verra ML, Irincheeva I, Bastiaenen CHG, Jakob SM. Functional ability and quality of life in critical illness survivors with intensive care unit acquired weakness: A secondary analysis of a randomised controlled trial. PLoS One. 2020 Mar 4;15(3):e0229725. doi: 10.1371/journal.pone.0229725. eCollection 2020.
Reference Type
BACKGROUND
Das Neves AV, Vasquez DN, Loudet CI, Intile D, Saenz MG, Marchena C, Gonzalez AL, Moreira J, Reina R, Estenssoro E. Symptom burden and health-related quality of life among intensive care unit survivors in Argentina: A prospective cohort study. J Crit Care. 2015 Oct;30(5):1049-54. doi: 10.1016/j.jcrc.2015.05.021. Epub 2015 Jun 3.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
http://revista.ajrpt.com/index.php/Main/article/view/88
Das Neves A, Busico M, Yanes N. Síndrome post terapia intensiva. Evaluación, prevención y seguimiento. En: Programa de actualización en kinesiología intensivista (PROAKI), ciclo 2, módulo 4. Editorial Médica Panamericana. Vol. 4. 2015.
https://clincalc.com/IcuMortality/Default.aspx
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAnchorenaSanMartin
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Reliability and Validity of a New Postoperative Track Assessment Tool
NCT05092867
COMPLETED
Postoperative Intensive Care Surveillance
NCT02894788
COMPLETED
Agitation Follow up After Introduction of a New Patient Care Algorithm
NCT04053426
COMPLETED
Postoperative Residual Paralysis After Cardiac Surgery
NCT03291184
COMPLETED
NA
Functional Recovery Over the First Year After ICU Discharge
NCT04206306
COMPLETED
Episodes of (Dis)Connected Consciousness in ICU Survivors
NCT07048951
RECRUITING
Regional Anaesthesia in Intensive Care Unit
NCT05131633
COMPLETED
Post-ICU Consultation : a Time to Discuss Advance Directives (CoPRADA)
NCT05817500
COMPLETED
Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery
NCT03805880
COMPLETED
Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators
NCT05384613
COMPLETED
Improved ICU Outcomes With Protocolized Management of Analgesia, Sedation and Delirium
NCT00506649
COMPLETED
Post Operative Cognitive Dysfunction
NCT03067259
COMPLETED
NA
Prevalence of Post Anesthesia Care Unit Complications and Associated Factors
NCT06815510
RECRUITING
Observational Study of Early Postoperative Deterioration and Complications
NCT06013891
COMPLETED
The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go!
NCT06344013
COMPLETED
The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
NCT03774342
UNKNOWN
Patient's Perception of Hospital Safety
NCT02820545
COMPLETED
(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
NCT05768906
COMPLETED
Postoperative Cognitive Dysfunction in Elderly
NCT02068742
UNKNOWN
NA
Continuous Deep Sedation Until Death
NCT05108792
COMPLETED
Quality of Recovery in the Post-anesthesia Care Unit
NCT06905353
NOT_YET_RECRUITING
Reducing Discomforts in Critically Ill Patients: the IPREA3 Study
NCT02442934
COMPLETED
NA
Anesthesia Quality Improvement and Patients With Planned ICU Admission
NCT05626153
COMPLETED
NA