Postoperative Complications Clinical Trial
— EXTUBPOSOfficial title:
The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery
Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations
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. |
Country | Name | City | State |
---|---|---|---|
France | Hop Claude Huriez Chu Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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 |
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