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Patient-ventilator Synchronisation Study for Intensive Care Unit Patients

NCT03787173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-01-28

No results posted yet for this study

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

Interventions

DEVICE

Optimized

Inspiratory trigger and Expiratory trigger settings optimized by investigator

DEVICE

Automated

Inspiratory trigger and Expiratory trigger settings automatized

Sponsors & Collaborators

  • Hamilton Medical AG

    collaborator INDUSTRY

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • Aude Garnero, MD · Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2024-04-16
Completion
2024-04-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787173 on ClinicalTrials.gov