NCT Number: NCT06499389
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN, Lyon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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
Time frame: At Hour 24
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, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
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
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
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
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
Measurements of bronchial secretion quantity using a 5-level Likert scale (0 to 4). The intensity of bronchial secretion quantity is graded semi-quantitatively by observing the quantity of secretions mobilized and/or present in the patient's airways.
Time frame: At Hour 24 and after every respiratory physiotherapy session
Number of physiotherapy sessions with mean arterial pressure < 65 mmHg. Hemodynamic instability is defined as the appearance of mottles, a mean arterial pressure < 65 mm Hg and requiring urgent intervention.
Time frame: At Hour 24, Day 7
Ratios of arterial partial pressure in O2 to inspired fraction in O2 measured on the ventilator (P/F ratio). In extubated, non-ventilated patients, fraction of inspired oxygen (FiO2) will be estimated using the following formula: 〖fraction inspired oxygen (FiO)〗_2 (%)=21+O2 flow (in L/min)× 3. Partial oxygen pressure (PaO2) is measured on arterial blood gas.
Time frame: At Hour 24, Day 7
Rate of barotraumatic complications. Thoracic (X-ray or computed tomography (CT) scan for pneumomediastinum and pneumothorax) or clinical examination (subcutaneous emphysema).
Time frame: At Hour 24, Day 7
Rate of reintubation
Time frame: Up to 60 days
Time, in days, between inclusion and successful liberation from the ventilator
Time frame: Up to 60 days
Time alive and free from invasive mechanical ventilation. A VFD of 0 is adjudicated to patients who died over that period, even if they were liberated from mechanical ventilation.
Time frame: Up to 60 days
Elapsed time, in days, between inclusion and ICU discharge
Contact information is provided by the study sponsor or research team.
Laurent BITKER, MD, PhD
CONTACT
04 26 10 94 93 ext. +33
Maria CLEYET, MSc
CONTACT
04 26 10 94 93 ext. +33
Hospices Civils de Lyon
Other
Randomized Controlled Trial Evaluating the Impact of Intensive, Instrumental and Early Respiratory Physiotherapy on Peak Expiratory Flow in Mechanically Ventilated Patients With ICU-acquired Muscle Weakness
Acronym: PHYSIO WEAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07445035
Exercise Training, Exoskeleton Device
New Taipei City, Taiwan
View Trial DetailsNCT07571317
Critical Illness, Disease Attributes
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07098611
Extubation Failure, Extubation Readiness
Punta Arenas, Chile
View Trial DetailsNCT06321848
Ultrasound, Ventilator Weaning
Hanoi, Vietnam
View Trial Details