Extubation, Lung Ultrasound Score, Postoperative Complications
Conditions
Keywords
positive pressure extubation, Postoperative Complications, lung ultrasound score
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
Interventions
PROCEDUREpositive pressure during extubation procedure
positive pressure during extubation procedure
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
patients under anaesthesia at randomization
Intervention model description
Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| desaturations during extubation | 1 minute after extubation | saturation \<92% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| desaturation postoperatory | 5 and 30 minutes after extubation | saturation\<92% |
| hypoxemia post operatory | 1 and 30 minutes after extubation | PaO2 \<60mmHg |
| atelectasis | 30 minutes after extubation | Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome |
| awakening time | through extubation completion, an average 2 minutes | time in seconds |
| use of oxygen | day 7 | days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation |
| post operative complications | day 7 and day 28 | Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome |
| feasibility and acceptance of both techniques pressure positive extubation | 15 minutes after extubation | questionnaire, min = 4, max =20, higher scores mean is worse outcome |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCédric CIRENEI, MD
University Hospital, Lille
Outcome results
None listed