Patient-ventilator Synchronisation Study for Intensive Care Unit Patients

NCT03787173 | Completed

• 2 other identifiers: 2018-CHITS-012018-A00658-47
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Failure

Keywords

non invasive ventilation; patient ventilator synchrony; acute respiratory failure; closed loop ventilation

Outcome Measures

Primary Outcomes (1)

• Asynchrony index

  Ratio between the total number of asynchronies divided by the number of patient inspiratory effort

  Continuous measurement over 30min

Secondary Outcomes (10)

• Lineffective inspiratory effort index

  Continuous measurement over 30min

• Autotrigering index

  Continuous measurement over 30min

• Double triggering index

  Continuous measurement over 30min

• Inspiratory trigger delay

  Continuous measurement over 30min

• Cycling delay

  Continuous measurement over 30min

Study Arms (3)

Manual standard ventilator settings

NO INTERVENTION

Inspiratory trigger set at 2 l/min, Expiratory trigger set at 25% of peak inspiratory flow

Manual optimized ventilator settings

ACTIVE COMPARATOR

Inspiratory trigger and Expiratory trigger settings optimized by investigator

Device: Optimized

Automated ventilator settings

EXPERIMENTAL

Inspiratory trigger and Expiratory trigger settings automatized

Device: Automated

Interventions

Optimized DEVICE

Inspiratory trigger and Expiratory trigger settings optimized by investigator

Manual optimized ventilator settings

Automated DEVICE

Inspiratory trigger and Expiratory trigger settings automatized

Automated ventilator settings

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Hamilton Medical AG: collaborator

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

Related Publications (5)

• 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.

  PMID: 26464393 BACKGROUND

• 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.

  PMID: 16799775 BACKGROUND

• 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.

  PMID: 21324867 BACKGROUND

• 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.

  PMID: 16224108 BACKGROUND

• 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.

  PMID: 16737982 BACKGROUND

Study Officials

• Aude Garnero, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: April 17, 2019
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)