Clinical trial NCT05295095: Does Positive Pressure Extubation Reduce Postoperative Desaturation?
Official title: The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extubation
Postoperative Complications
Lung Ultrasound Score
Keywords: positive pressure extubation
Postoperative Complications
lung ultrasound score
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
Primary purpose: TREATMENT

Brief summary: Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations

Detailed description: Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Eligibility criteria: Inclusion Criteria:

* Visceral or urological surgery
* Scheduled surgery
* Surgical or patient requirement: placement of an arterial catheter
* Supine position
* Post-surgical extubation scheduled in the operating room
* Minimum age of 18 years
* Informed and signed consent

Exclusion Criteria:

* Severe obesity (BMI over 35kg/m2)
* pregnant woman
* Acute or chronic preoperative respiratory pathology.
* Sleep apnea syndrome
* Inability to receive informed information (does not speak, read or understand French)
* Patient under guardianship or curatorship
* Lack of social security coverage
* History of intubation or criteria for difficult intubation or ventilation.

Primary outcomes:
measure: desaturations during extubation
timeFrame: 1 minute after extubation
Secondary outcomes:
measure: desaturation postoperatory
timeFrame: 5 and 30 minutes after extubation
measure: hypoxemia post operatory
timeFrame: 1 and 30 minutes after extubation
measure: atelectasis
timeFrame: 30 minutes after extubation
measure: awakening time
timeFrame: through extubation completion, an average 2 minutes
measure: use of oxygen
timeFrame: day 7
measure: post operative complications
timeFrame: day 7 and day 28
measure: feasibility and acceptance of both techniques pressure positive extubation
timeFrame: 15 minutes after extubation
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Cédric CIRENEI, MD
role: PRINCIPAL_INVESTIGATOR
References: