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Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

ConditionVentilator Weaning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

Difficult ventilatory weaning is associated with a 20% mortality rate. 40% of these patients will develop intensive care unit (ICU)-acquired neuromyopathy, associated with reduced cough strength and a 4-fold increase in the risk of reintubation. The objective measure of cough strength is peak expiratory flow (PEF). Instrument-assisted coughing is a respiratory physiotherapy technique capable of significantly increasing PEF in chronic neuromuscular patients and draining bronchial secretions.

The objective of the study is to determine whether an early, systematic, instrumental, intensive respiratory physiotherapy strategy in patients with difficult ventilatory weaning and ICU-acquired neuromyopathy significantly improves PEF immediately prior to extubation, compared with a conventional, protocolized management strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient 18 years or more, affiliated to a social security system

Patients on invasive mechanical ventilation for 48 hours or more

Failure of at least one mechanical ventilation weaning test (spontaneous breathing trial, SBT)

First successful SBT on the day of eligibility assessment

Disqualifiers

Recent brain injury (< 3 months, stroke, cardiopulmonary arrest)

Delirium tremens (Cushman score > 7)

Chronic neuromuscular pathology

Patient under continuous intravenous sedation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning

    Procedure/Surgery

    Patients randomized to this group will receive 3 sessions per day of intensive early respiratory physiotherapy with instrumental techniques from randomization to day 7, before and after any extubation. The strategy will be applied until day 7 of randomization, regardless of the patient's status (intubated or not).

  • Protocolized standard-of-care respiratory physiotherapy

    Procedure/Surgery

    Patients in this group will receive standardized and protocolized respiratory physiotherapy to reproduce the usual practices of non-expert centers,1 to 2 sessions of manual respiratory physiotherapy (not assisted by an instrumental technique) per day until the day of successful extubation, or until day 7 if necessary

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intensive instrumental and early respiratory physiotherapyExperimental treatment 1 intervention
Group B: Protocolized standard-of-care respiratory physiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort

PECF measured on the ventilator using its built-in flowmeter (PECF on unassisted coughing under mechanical ventilation). PECF is expressed in L/min.

Time frame
At Hour 24

Secondary outcomes

1

Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort

PECF measured by a spirometer without ventilation, either in intubated patients after disconnection from the ventilator, and in extubated patients by application of a naso-buccal mask connected to the spirometer. PECF is expressed in L/min.

Time frame
At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
2

Assisted PECF under mechanical ventilation

PECF measured by the spirometer during the application of mechanical (instrumental) cough assistance by connecting the spirometer between the intubation tube and the Cough Assist E70 in the intubated patient, or between the nasobuccal mask and the Cough Assist E70 in the extubated patient. PECF is expressed in L/min.

Time frame
At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
3

Semi-quantitative measurement of cough strength

Measurements of cough strength using a 6-level Likert scale (0-5) for intubated patients.

Time frame
At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
4

Semi-quantitative measurement of cough strength

Measurements of cough strength using a 4-level Likert scale (0-3) for extubated patients.

Time frame
At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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