Clinical trial NCT05796297: Clinical Impact of Patient-ventilator Asynchrony
Official title: Clinical Impact of Patient Ventilator Asynchrony in Patients With Chronic Respiratory Failure on Long-term Ventilation : a Prospective, Monocentric, Open-label Epidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Respiratory Failure
Non-invasive Ventilation
Asynchrony Between Patient and Ventilator
Efficacy and Tolerance of Non-invasive Ventilation
Clinical Repercussions of the Various Patient-ventilator Asynchronies
Keywords: Tolerance
Efficiency
Patient ventilator asynchrony
NIV
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic respiratory insufficiency fitted with long-term NIV, whatever the reason for the chronic respiratory insufficiency.

A transcutaneous capnography within 15 days preceding the follow-up consultation and obtaining the SIM card containing the machine data will be required to be included in the study.

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

Eligibility criteria: Inclusion Criteria :

* Women and Men aged of at least 18 years old.
* NIV equipment since 6 months ( at least)
* Chronic respiratory failure requiring NIV equipment defined by clinical symptoms (asthenia, excessive daytime sleepiness, headache, dyspnea) and:

In case of obstructive diseases :

Daytime hypercapnia (PaCO2 \> 55 mmHg) or Daytime hypercapnia between 50-54 mmHg associated with nocturnal desaturations (at least 5 min below 88% saturation) or episodes of frequent hypercapnic exacerbations (at least 2 over the last 12 months)

In case of restrictive diseases :

Daytime hypercapnia (PaCO2\>6 kPa (kilopascal) or 45 mm Hg) or Nocturnal desaturation (SaO2 \< 88%) for at least 5 minutes without obstructive sleep apnea syndrome (OSAS) found or Marker of progression of neuromuscular damage (Maximum inspiratory pressure \< 60 cm H2O and forced vital capacity (FVC) less than 50% of theory)

* NIV's start from at least 6 months.
* Patient who did not object to being included in the study.
* Patient in stable condition without exacerbation (for at least 3 months)

Exclusion Criteria :

* Minor patient
* Pregnant or breastfeeding women
* Adult patient subject to enhanced protection, deprived of liberty by judicial or administrative decision.
* Patient who is physically or psychologically unable to follow the protocol in an informed manner.
* Patient with chronic respiratory failure requiring mechanical ventilation by tracheotomy
* Patient having changed center or service provider (data not available).
* Patient who objected to being included in the study

Primary outcomes:
measure: Ventilation's efficiency/tolerance
timeFrame: Up to 14 days
Secondary outcomes:
measure: Estimation of quality of life with non-invasive ventilation
timeFrame: Up to 14 days
measure: Estimation of quality of sleep with non-invasive ventilation
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: JAFFRE, PH
role: PRINCIPAL_INVESTIGATOR
References: