Reliability of PVI Changes During Tidal Volume Challenge in ICU Patients

NCT05428423 | Unknown

• 1 other identifier: IDRCB:2022-A01253-40
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shock; Septic Shock; Sepsis; Hemodynamic Instability

Keywords

Tidal volume challenge; Pleth variability index

Outcome Measures

Primary Outcomes (1)

• Reliability of PVI changes in diagnosing preload responsiveness during TVC

  The primary objective is to assess the reliability of PVI changes induced by a tidal volume challenge test in diagnosing a preload responsiveness state in adult ICU patients.

  TVC is performed in 1 minute

Secondary Outcomes (3)

• Reliability of PVI absolute values to diagnose preload responsiveness

  TVC is performed in 1 minute

• Evaluation of PVI changes during TVC according to sensor position

  TVC is performed in 1 minute

• Comparison of PPV and PVI changes during PLR test or volume expansion

  PLR is performed in 1 minute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in intensive care unit, mechanically ventilated with a tidal volume of 6 ml/kg on ideal body weight, with oxygen saturation monitoring with Masimo SET and cardiac output monitoring with PICCO2 system in place.

You may qualify if:

• 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

You may not qualify if:

• thoracic drainage
• patient under judicial protection

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Service de médecine intensive-réanimation, Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Related Publications (15)

• 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.

  PMID: 21906322 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.

  PMID: 16714767 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.

  PMID: 27922879 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.

  PMID: 33555488 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.

  PMID: 17393139 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.

  PMID: 16424713 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.

  PMID: 17122227 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.

  PMID: 17525584 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.

  PMID: 17054816 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.

  PMID: 18522935 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.

  PMID: 18946297 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.

  PMID: 31068139 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.

  PMID: 23103777 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.

  PMID: 30851740 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.

  PMID: 33736672 BACKGROUND

MeSH Terms

Conditions

Shock; Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Xavier Monnet, MD-PhD

  Hopital de Bicetre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Monnet, MD-PhD

CONTACT

+33 06 60 86 26 69; xavier.monnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 6, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

FR (1)