Reliability of PVI Changes During Tidal Volume Challenge in ICU Patients

Sepsis Clinical Trial

Official title:

Assessment of the Reliability of Changes in Plethysmography Variability Index During Tidal Volume Challenge for Predicting Fluid Responsiveness in Intensive Care Unit Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428423
• Other study ID #: IDRCB:2022-A01253-40
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: November 2022

Study information

• Verified date: November 2022
• Source: Bicetre Hospital
• Contact: Xavier Monnet, MD-PhD
• Phone: +33 06 60 86 26 69
• Email: xavier.monnet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• thoracic drainage

• patient under judicial protection

Related Conditions & MeSH terms

• Hemodynamic Instability
• Sepsis
• Septic Shock
• Shock

Locations

Country	Name	City	State
France	Service de médecine intensive-réanimation, Hôpital de Bicêtre	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

References & Publications (15)

Alvarado Sánchez JI, Caicedo Ruiz JD, Diaztagle Fernández JJ, Amaya Zuñiga WF, Ospina-Tascón GA, Cruz Martínez 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. Review. — View Citation

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. — View Citation

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. Epub 2006 Oct 23. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Mar 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Monnet X, Guérin 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 May 21. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reliability of PVI absolute values to diagnose preload responsiveness	Secondary objective is to test the reliability of absolute values of PVI to diagnose a preload responsiveness state in adult intensive care patients.	TVC is performed in 1 minute
Secondary	Evaluation of PVI changes during TVC according to sensor position	Third objective is to compare the value of changes in PVI induced by a tidal volume challenge test to diagnose a preload responsiveness state according to the location of the plethysmographic measurement (finger, earlobe, forehead).	TVC is performed in 1 minute
Secondary	Comparison of PPV and PVI changes during PLR test or volume expansion	Forth objective is to compare the changes in pulse pressure variation (PPV) and PVI during a passive leg raising test (PLR) and a volume expansion, if applicable.	PLR is performed in 1 minute