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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
First received
Last updated
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
Health authority
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.

Study Design


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
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