Patient-ventilator Synchronisation Study for Intensive Care Unit Patients

Acute Respiratory Failure Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787173
• Other study ID #: 2018-CHITS-01
• Secondary ID: 2018-A00658-47
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: April 16, 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Optimized
Inspiratory trigger and Expiratory trigger settings optimized by investigator
• Automated
Inspiratory trigger and Expiratory trigger settings automatized

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Hamilton Medical AG

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony index	Ratio between the total number of asynchronies divided by the number of patient inspiratory effort	Continuous measurement over 30min
Secondary	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
Secondary	Autotrigering index	Ratio between the total number of autotriggered breath divided by the number of patient inspiratory effort	Continuous measurement over 30min
Secondary	Double triggering index	Ratio between the total number of double triggered breath divided by the number of patient inspiratory effort	Continuous measurement over 30min
Secondary	Inspiratory trigger delay	Time between the beginning of patient effort assessed on oesophageal pressure and beginning of mechanical breath.	Continuous measurement over 30min
Secondary	Cycling delay	Time between the end of patient effort assessed on oesophageal pressure and the end of mechanical breath.	Continuous measurement over 30min
Secondary	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
Secondary	Patient comfort	Visual analog scale of Likert type measuring patient comfort going from 0 (very uncomfortable) to 10 (very comfortable)	1 day (Single measurement)
Secondary	Blood PaO2 results	PaO2	After each period at 30 min, 1 h and 1 h 30 min
Secondary	Blood PaCO2 results	PaCO2	After each period at 30 min, 1 h and 1 h 30 min
Secondary	Blood pH results	pH	After each period at 30 min, 1 h and 1 h 30 min