Does Positive Pressure Extubation Reduce Postoperative Desaturation?

Postoperative Complications Clinical Trial

— EXTUBPOS  

Official title:

The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295095
• Other study ID #: 2021_0433
• Secondary ID: 2021-A03064-37
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: July 2024

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Cédric CIRENEI, MD
• Phone: 0320445962
• Email: cedric.cirenei[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extubation
• Lung Ultrasound Score
• Postoperative Complications

Intervention

Procedure:
• positive pressure during extubation procedure
positive pressure during extubation procedure

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	desaturations during extubation	saturation <92%	1 minute after extubation
Secondary	desaturation postoperatory	saturation<92%	5 and 30 minutes after extubation
Secondary	hypoxemia post operatory	PaO2 <60mmHg	1 and 30 minutes after extubation
Secondary	atelectasis	Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome	30 minutes after extubation
Secondary	awakening time	time in seconds	through extubation completion, an average 2 minutes
Secondary	use of oxygen	days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation	day 7
Secondary	post operative complications	Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome	day 7 and day 28
Secondary	feasibility and acceptance of both techniques pressure positive extubation	questionnaire, min = 4, max =20, higher scores mean is worse outcome	15 minutes after extubation