Clinical Impact of Patient-ventilator Asynchrony

Completed

• Conditions: Chronic Respiratory Failure; Efficacy and Tolerance of Non-invasive Ventilation; Clinical Repercussions of the Various Patient-ventilator Asynchronies; Non-invasive Ventilation; Asynchrony Between Patient and Ventilator
• Interventions: Device: Transcutaneous Capnography

• Registration Number: NCT05796297
• Lead Sponsor: Nantes University Hospital

Brief Summary

The investigator wish to carry out this study to explore the link between patient-ventilator asynchrony with the efficiency and tolerance of NIV but also the quality of life in patients with chronic respiratory failure on long-term ventilation.

Detailed Description

Chronic respiratory failure (CRF) is an advanced stage of many respiratory diseases marked by an inability of the respiratory system to ensure vital gas exchange. It affects approximately 3.6 million people in France.

Non-invasive ventilation (NIV) remains the reference treatment in hypercapnic respiratory failure because it reduces inspiratory muscles's work and promotes alveolar ventilation.

The establishment of the NIV is carried out most of the time following an episode of acute decompensation revealing an underlying CRF. It is carried out and supervised in hospital departments to optimize the understanding and adherence of the patient to his illness and his treatment.

Thus, monitoring is a key to measure the tolerance and effectiveness of ventilation. Classically, it is based on multi-year medical consultations, blood gases and nocturnal oximetry. In recent years, the reading of detailed data from software integrated into NIV machines has been increasingly used in current practice in association with the monitoring tools already recommended. It provides additional detailed information on compliance, leaks, apnea-hypopnea index (AHI), obstructive events and asynchrony between the patient and their ventilator.

Many patient-ventilator asynchronies have been described in studies with a negative impact on the quality of ventilation, the quality of sleep under NIV and an increased risk of mortality. However, not all asynchronies have the same consequences and are not all felt by the patient

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2023-06-01
• Primary Completion: 2024-04-14
• Study Completion: 2024-04-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient without significant patient ventilator asynchrony	Transcutaneous Capnography	Active Comparator
Patient with significant patient ventilator asynchrony	Transcutaneous Capnography	Active Comparator

Primary Outcome Measures

Name	Time	Method
Ventilation's efficiency/tolerance	Up to 14 days	Presence of a significant rate of patient-ventilator asynchrony when reading the ventilation curves of the NIV machine data.

Secondary Outcome Measures

Name	Time	Method
Estimation of quality of life with non-invasive ventilation	Up to 14 days	Estimation of perceived quality of life through the S3-Non Invasive Ventilation questionnaire (scale from 0 to 4 ; 0 being the worst outcome)
Estimation of quality of sleep with non-invasive ventilation	Up to 14 days	Estimation of perceived quality of sleep through the Epworth sleepiness scale (scale from 0 to 3 ; 3 being the worst outcome)

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France