Clinical trial NCT03787173: Patient-ventilator Synchronisation Study for Intensive Care Unit Patients
Official title: Patient-ventilator Synchronisation Study in Non Invasive Ventilation for Intensive Care Unit Patients: Comparison Between Manual and Automated Ventilator Settings.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: non invasive ventilation
patient ventilator synchrony
acute respiratory failure
closed loop ventilation
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Hamilton Medical AG
First posted: 2018-12-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asynchrony index
timeFrame: Continuous measurement over 30min
Secondary outcomes:
measure: Lineffective inspiratory effort index
timeFrame: Continuous measurement over 30min
measure: Autotrigering index
timeFrame: Continuous measurement over 30min
measure: Double triggering index
timeFrame: Continuous measurement over 30min
measure: Inspiratory trigger delay
timeFrame: Continuous measurement over 30min
measure: Cycling delay
timeFrame: Continuous measurement over 30min
measure: Total time spent in asynchrony
timeFrame: Continuous measurement over 30min
measure: Patient comfort
timeFrame: 1 day (Single measurement)
measure: Blood PaO2 results
timeFrame: After each period at 30 min, 1 h and 1 h 30 min
measure: Blood PaCO2 results
timeFrame: After each period at 30 min, 1 h and 1 h 30 min
measure: Blood pH results
timeFrame: After each period at 30 min, 1 h and 1 h 30 min
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Aude Garnero, MD
role: STUDY_DIRECTOR
References:
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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.