Patient-ventilator Synchronisation Study for Intensive Care Unit Patients (SyncAutoVNI)

Patient-ventilator Synchronisation Study in Non Invasive Ventilation for Intensive Care Unit Patients: Comparison Between Manual and Automated Ventilator Settings.

This cross-over study will compare the asynchrony index between standard manual ventilator settings, optimized manual ventilator settings, and automated ventilator setting in intensive care patients ventilated in non-invasive ventilation with a high asynchrony index. The hypothesis is that both manual optimized ventilator settings and automated ventilator settings are associated with a lower patient-ventilator asynchrony index as compared to manual standard ventilator settings.

A randomized cross-over design method will be used. Patient requiring NIV with an asynchrony index over 35% will be included. An esophageal catheter with a balloon will be inserted to monitor esophageal pressure. Patients will be ventilated during 3 periods of 30 min, with 10 minutes of washout in between. Recordings of airway pressure, airway flow, and esophageal pressure will be analyzed by two investigators blinded of the trigger settings.

The primary outcome will be the asynchrony index. The secondary outcome will be the ineffective inspiratory effort index, autotrigering index, double triggering index, inspiratory trigger delay, cycling delay, total time spent in asynchrony, patient comfort, and blood gas results.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Optimized; Device: Automated

Detailed Description

Non-invasive ventilation (NIV) is used in 35% of patient admitted in intensive care unit (ICU) with a failure rate of 10 to 70% depending on the indication and clinician experience. Patient-ventilator asynchrony is a frequent cause of NIV failure. Therefore, optimizing patient-ventilator synchronization is important for its comfort, tolerance, and efficacy. An optimal patient-ventilation is achieved when the mechanical breath provided by the ventilator match the patient inspiratory effort. The ratio between the number of asynchronies divided by the number of patient inspiratory effort define the asynchrony index (AI). AI over 10% is considered as severe and occurs in 30 to 43% of patients ventilated in NIV. Patient ventilator asynchronies occurs because ventilator settings of inspiratory and expiratory triggers remain constant in patient with variable respiratory drive, and unintentionnals leaks that are difficult to control in NIV. Thus using an automatic adjustment of inspiratory and expiratory triggers setting according to patient effort and unintentional leaks may decrease the number of patient-ventilator asynchronies. This cross-over study will compare the asynchrony index between standard manual ventilator settings, optimized manual ventilator settings, and automated ventilator setting in intensive care patients ventilated in non-invasive ventilation with a high asynchrony index. The hypothesis is that both manual optimized ventilator settings and automated ventilator settings are associated with a lower patient-ventilator asynchrony index as compared to manual standard ventilator settings.

A randomized cross-over design method will be used. Patient requiring NIV with an asynchrony index over 30% will be included. An esophageal catheter with a balloon will be inserted to monitor esophageal pressure. Patients will be ventilated during 3 periods of 30 min, with 10 minutes of washout in between. Recordings of airway pressure, airway flow, and esophageal pressure will be analyzed by two investigators blinded of the trigger settings.

The primary outcome will be the asynchrony index. The secondary outcome will be the ineffective inspiratory effort index, autotrigering index, double triggering index, inspiratory trigger delay, cycling delay, total time spent in asynchrony, patient comfort, and blood gas results.

The sample size was calculated from the total asynchrony index (primary outcome). Patients with an asynchrony index over 30% in using manual standard ventilator settings will be included. Considering an asynchrony index of 30 ± 15 % in manual standard ventilator settings with a clinically significant objective to reduce the asynchrony index to 15% in manual optimized ventilator settings and automated ventilator settings, a sample size of 30 patients is required with a risk at 0.05 and a power at 80%. Therefore, 35 patients are planned.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa Jobic; Phone Number: +33 04.83.77.20.61; Email: asmaa.jobic@ch-toulon.fr

Study Locations

• France
  • Var
    • Toulon, Var, France, 83056
      • Recruiting
      • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
      • Contact: Aude Garnero, MD; Phone Number: +33 04 94 14 58 62; Email: aude.garnero@gmail.com
      • Sub-Investigator: Jean-Michel Arnal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged over 18 years old
• Covered by social insurance
• Consent for study signed by patient or next-of-kin
• NIV session indicated for at least 2 hours
• Asynchrony index ≥ 30% with standard manual settings

Exclusion Criteria:

• Patient requiring continuous NIV
• Contra-indication to esophageal catheter insertion: gastric ulcer, esophageal varices, pharyngeal or laryngeal tumor.
• Patient with withholding decision about intubation
• Moribund patient
• Patient included in another interventional study in the last 30 days
• Patient that does not speak French
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Manual standard ventilator settings; Inspiratory trigger set at 2 l/min, Expiratory trigger set at 25% of peak inspiratory flow
Active Comparator: Manual optimized ventilator settings; Inspiratory trigger and Expiratory trigger settings optimized by investigator	Device: Optimized; Inspiratory trigger and Expiratory trigger settings optimized by investigator
Experimental: Automated ventilator settings; Inspiratory trigger and Expiratory trigger settings automatized	Device: Automated; Inspiratory trigger and Expiratory trigger settings automatized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchrony index	Ratio between the total number of asynchronies divided by the number of patient inspiratory effort	Continuous measurement over 30min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lineffective inspiratory effort index	Ratio between the total number of ineffective inspiratory effort divided by the number of patient inspiratory effort	Continuous measurement over 30min
Autotrigering index	Ratio between the total number of autotriggered breath divided by the number of patient inspiratory effort	Continuous measurement over 30min
Double triggering index	Ratio between the total number of double triggered breath divided by the number of patient inspiratory effort	Continuous measurement over 30min
Inspiratory trigger delay	Time between the beginning of patient effort assessed on oesophageal pressure and beginning of mechanical breath.	Continuous measurement over 30min
Cycling delay	Time between the end of patient effort assessed on oesophageal pressure and the end of mechanical breath.	Continuous measurement over 30min
Total time spent in asynchrony	Ratio of total time of ineffective inspiratory effort, inspiratory trigger delay, and cycling delay on total time of recording.	Continuous measurement over 30min
Patient comfort	Visual analog scale of Likert type measuring patient comfort going from 0 (very uncomfortable) to 10 (very comfortable)	1 day (Single measurement)
Blood PaO2 results	PaO2	After each period at 30 min, 1 h and 1 h 30 min
Blood PaCO2 results	PaCO2	After each period at 30 min, 1 h and 1 h 30 min
Blood pH results	pH	After each period at 30 min, 1 h and 1 h 30 min

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: Hamilton Medical AG
• Investigators: Study Director: Aude Garnero, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Publications and helpful links

General Publications

• Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.
• El-Solh AA, Aquilina A, Pineda L, Dhanvantri V, Grant B, Bouquin P. Noninvasive ventilation for prevention of post-extubation respiratory failure in obese patients. Eur Respir J. 2006 Sep;28(3):588-95. doi: 10.1183/09031936.06.00150705. Epub 2006 May 31.
• Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.
• Demoule A, Girou E, Richard JC, Taille S, Brochard L. Increased use of noninvasive ventilation in French intensive care units. Intensive Care Med. 2006 Nov;32(11):1747-55. doi: 10.1007/s00134-006-0229-z. Epub 2006 Jun 24.
• Keenan SP, Sinuff T, Burns KE, Muscedere J, Kutsogiannis J, Mehta S, Cook DJ, Ayas N, Adhikari NK, Hand L, Scales DC, Pagnotta R, Lazosky L, Rocker G, Dial S, Laupland K, Sanders K, Dodek P; Canadian Critical Care Trials Group/Canadian Critical Care Society Noninvasive Ventilation Guidelines Group. Clinical practice guidelines for the use of noninvasive positive-pressure ventilation and noninvasive continuous positive airway pressure in the acute care setting. CMAJ. 2011 Feb 22;183(3):E195-214. doi: 10.1503/cmaj.100071. Epub 2011 Feb 14. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Estimated): April 16, 2024
• Study Completion (Estimated): April 16, 2024

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: non invasive ventilation; acute respiratory failure; patient ventilator synchrony; closed loop ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2018-CHITS-01; 2018-A00658-47 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No