Reliability of PVI Changes During Tidal Volume Challenge in ICU Patients
NCT ID: NCT05428423
Last Updated: 2022-11-23
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
UNKNOWN
Total Enrollment
44 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-06-06
Study Completion Date
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance
NCT07131228
Venous Congestion
NOT_YET_RECRUITING
Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Mechanically Ventilated Patients Under Spontaneous Mode
NCT06495489
General Critically Ill Patients With Hypovolemia
COMPLETED
Fluid Management Based on Pleth Variability Index (PVI) Monitoring During High-risk Surgery
NCT01788293
Fluid Loss
TERMINATED
NA
IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension
NCT04238234
Hypotension on Induction
UNKNOWN
Transducer Levelling Errors in Everyday ICU Practice - A Multicentre Blinded Observational Study
NCT07330505
Critically Ill
Haemodynamic Instability
NOT_YET_RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Among patients in a state of shock one of the first treatments is volume expansion, consisting in a fast intravenous injection of crystalloid or colloid solutions in order to increase cardiac preload and consequently cardiac output. However, this augmentation of the cardiac output happens only in half of the patients.To avoid ineffective fluid administration several tests have been developed.
One of these tests is called the "tidal volume challenge" (TVC). It consists of transiently increasing for 1 minute the volume of air inhaled with each breath, in mechanically ventilated patients, and then evaluating whether this change impacts the pulsatility of the arterial blood pressure, detected by an arterial catheter. This test seems reliable, but it requires an arterial catheter to be in place.
It has been suggested in previous studies that pulsatility of blood pressure can be estimated by the pulsatility of the plethysmography signal ("plethysmography variability index"), obtained from the oxygen saturation signal that's measured in all intensive care patients. The advantage is that this measurement only requires a sensor placed at the end of a finger, on the earlobe or on the forehead.
The aim of the study is to assess whether changes in the plethysmography variability index (PVI) during a TVC can reliably detect simultaneous changes in blood pressure pulsatility. This study will include patients hospitalized in intensive care unit, mechanically ventilated, in whom physicians have decided to perform a TVC as common practice. Changes, occurred during this test, in arterial blood pressure pulsatility and in plethysmography pulsatility index will be measured and compared. If results will show that changes in PVI during TVC are reliable for measuring blood pressure pulsatility changes during this test, this will allow the test to be used even in the absence of an arterial catheter.
One of these tests is called the "tidal volume challenge" (TVC). It consists of transiently increasing for 1 minute the volume of air inhaled with each breath, in mechanically ventilated patients, and then evaluating whether this change impacts the pulsatility of the arterial blood pressure, detected by an arterial catheter. This test seems reliable, but it requires an arterial catheter to be in place.
It has been suggested in previous studies that pulsatility of blood pressure can be estimated by the pulsatility of the plethysmography signal ("plethysmography variability index"), obtained from the oxygen saturation signal that's measured in all intensive care patients. The advantage is that this measurement only requires a sensor placed at the end of a finger, on the earlobe or on the forehead.
The aim of the study is to assess whether changes in the plethysmography variability index (PVI) during a TVC can reliably detect simultaneous changes in blood pressure pulsatility. This study will include patients hospitalized in intensive care unit, mechanically ventilated, in whom physicians have decided to perform a TVC as common practice. Changes, occurred during this test, in arterial blood pressure pulsatility and in plethysmography pulsatility index will be measured and compared. If results will show that changes in PVI during TVC are reliable for measuring blood pressure pulsatility changes during this test, this will allow the test to be used even in the absence of an arterial catheter.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Shock
Septic Shock
Sepsis
Hemodynamic Instability
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients hospitalized in intensive care unit
* physicians' decision to perform a tidal volume challenge
* hemodynamic monitoring with a calibrated pulse contour analysis device (PICCO2) in place
* monitoring of oxygen saturation with Masimo SET
* mechanical ventilation with tidal volume of 6 ml/kg on ideal body weight
* physicians' decision to perform a tidal volume challenge
* hemodynamic monitoring with a calibrated pulse contour analysis device (PICCO2) in place
* monitoring of oxygen saturation with Masimo SET
* mechanical ventilation with tidal volume of 6 ml/kg on ideal body weight
Exclusion Criteria
* thoracic drainage
* patient under judicial protection
* patient under judicial protection
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.
Bicetre Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xavier Monnet
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xavier Monnet, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital de Bicetre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Service de médecine intensive-réanimation, Hôpital de Bicêtre
Le Kremlin-Bicêtre, , France
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
France
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.
Reference Type
BACKGROUND
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
Reference Type
BACKGROUND
Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.
Reference Type
BACKGROUND
Alvarado Sanchez JI, Caicedo Ruiz JD, Diaztagle Fernandez JJ, Amaya Zuniga WF, Ospina-Tascon GA, Cruz Martinez LE. Predictors of fluid responsiveness in critically ill patients mechanically ventilated at low tidal volumes: systematic review and meta-analysis. Ann Intensive Care. 2021 Feb 8;11(1):28. doi: 10.1186/s13613-021-00817-5.
Reference Type
BACKGROUND
Feissel M, Teboul JL, Merlani P, Badie J, Faller JP, Bendjelid K. Plethysmographic dynamic indices predict fluid responsiveness in septic ventilated patients. Intensive Care Med. 2007 Jun;33(6):993-9. doi: 10.1007/s00134-007-0602-6. Epub 2007 Mar 29.
Reference Type
BACKGROUND
Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.
Reference Type
BACKGROUND
Natalini G, Rosano A, Taranto M, Faggian B, Vittorielli E, Bernardini A. Arterial versus plethysmographic dynamic indices to test responsiveness for testing fluid administration in hypotensive patients: a clinical trial. Anesth Analg. 2006 Dec;103(6):1478-84. doi: 10.1213/01.ane.0000246811.88524.75.
Reference Type
BACKGROUND
Cannesson M, Attof Y, Rosamel P, Desebbe O, Joseph P, Metton O, Bastien O, Lehot JJ. Respiratory variations in pulse oximetry plethysmographic waveform amplitude to predict fluid responsiveness in the operating room. Anesthesiology. 2007 Jun;106(6):1105-11. doi: 10.1097/01.anes.0000267593.72744.20.
Reference Type
BACKGROUND
Cannesson M, Desebbe O, Hachemi M, Jacques D, Bastien O, Lehot JJ. Respiratory variations in pulse oximeter waveform amplitude are influenced by venous return in mechanically ventilated patients under general anaesthesia. Eur J Anaesthesiol. 2007 Mar;24(3):245-51. doi: 10.1017/S026502150600161X. Epub 2006 Oct 23.
Reference Type
BACKGROUND
Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
Reference Type
BACKGROUND
Landsverk SA, Hoiseth LO, Kvandal P, Hisdal J, Skare O, Kirkeboen KA. Poor agreement between respiratory variations in pulse oximetry photoplethysmographic waveform amplitude and pulse pressure in intensive care unit patients. Anesthesiology. 2008 Nov;109(5):849-55. doi: 10.1097/ALN.0b013e3181895f9f.
Reference Type
BACKGROUND
Liu T, Xu C, Wang M, Niu Z, Qi D. Reliability of pleth variability index in predicting preload responsiveness of mechanically ventilated patients under various conditions: a systematic review and meta-analysis. BMC Anesthesiol. 2019 May 8;19(1):67. doi: 10.1186/s12871-019-0744-4.
Reference Type
BACKGROUND
Monnet X, Guerin L, Jozwiak M, Bataille A, Julien F, Richard C, Teboul JL. Pleth variability index is a weak predictor of fluid responsiveness in patients receiving norepinephrine. Br J Anaesth. 2013 Feb;110(2):207-13. doi: 10.1093/bja/aes373. Epub 2012 Oct 26.
Reference Type
BACKGROUND
Coeckelenbergh S, Delaporte A, Ghoundiwal D, Bidgoli J, Fils JF, Schmartz D, Van der Linden P. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Mar 9;19(1):34. doi: 10.1186/s12871-019-0707-9.
Reference Type
BACKGROUND
Taccheri T, Gavelli F, Teboul JL, Shi R, Monnet X. Do changes in pulse pressure variation and inferior vena cava distensibility during passive leg raising and tidal volume challenge detect preload responsiveness in case of low tidal volume ventilation? Crit Care. 2021 Mar 18;25(1):110. doi: 10.1186/s13054-021-03515-7.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDRCB:2022-A01253-40
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse
NCT03184207
COMPLETED
Plethysmography Variability Index as an Indicator of Adequacy of Preload
NCT01285622
COMPLETED
Intraoperative Pleth Variability Index (PVI) Variability
NCT03215238
TERMINATED
The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
NCT03048162
COMPLETED
NA
Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.
NCT02439242
UNKNOWN
Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)
NCT01673230
COMPLETED
NA
Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness
NCT03673475
COMPLETED
Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness
NCT02122367
UNKNOWN
PHASE4
Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling.
NCT04732481
COMPLETED
Applicability of Fluid Responsiveness Indices in Circulatory Failure (AFRIC Study) Study Project
NCT05046340
UNKNOWN
Conventional Fluid Management vs Plethysmographic Variability Index -Based Goal Directed Fluid Management
NCT05239286
COMPLETED
NA
Paired Comparison of SVV and PVI Accuracy
NCT07260890
RECRUITING
Accuracy of the Pleth Variability Index to Predict Fluid Responsiveness in Liver Transplantation
NCT01792011
COMPLETED
PHASE4
Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients
NCT02789124
COMPLETED
NA
Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension
NCT04991220
UNKNOWN
NA
Preload Dependence During Prone Position In ARDS Patients
NCT01965574
COMPLETED
NA
Pleth Variability Index and Fluid Management During Surgery
NCT00816153
COMPLETED
NA
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table
NCT02826889
COMPLETED
NA
Peripheral Tissue Perfusion in Intensive Care
NCT06384287
RECRUITING
Management of Intraoperative Fluids in Ambulatory Surgery
NCT03193320
UNKNOWN
NA
Pontos-Central Venous Pressure and Cardiac Surgery
NCT03423420
COMPLETED
NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock
NCT00736723
COMPLETED
Hypotension Prediction During Cardiac Surgery Postoperative Period
NCT05840432
UNKNOWN