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Does Positive Pressure Extubation Reduce Postoperative Desaturation? (EXTUBPOS)

Primary Purpose

Extubation, Postoperative Complications, Lung Ultrasound Score

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
positive pressure during extubation procedure
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extubation focused on measuring positive pressure extubation, Postoperative Complications, lung ultrasound score

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

VSPEP

VSAIPEP

Arm Description

Classical extubation technique : ETT was removed with continuous endotracheal suction

ETT was removed with APL valve set to 20cmH2O

ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Outcomes

Primary Outcome Measures

desaturations during extubation
saturation <92%

Secondary Outcome Measures

desaturation postoperatory
saturation<92%
hypoxemia post operatory
PaO2 <60mmHg
atelectasis
Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome
awakening time
time in seconds
use of oxygen
days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation
post operative complications
Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome
feasibility and acceptance of both techniques pressure positive extubation
questionnaire, min = 4, max =20, higher scores mean is worse outcome

Full Information

First Posted
February 21, 2022
Last Updated
July 7, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT05295095
Brief Title
Does Positive Pressure Extubation Reduce Postoperative Desaturation?
Acronym
EXTUBPOS
Official Title
The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extubation, Postoperative Complications, Lung Ultrasound Score
Keywords
positive pressure extubation, Postoperative Complications, lung ultrasound score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
Masking
Participant
Masking Description
patients under anaesthesia at randomization
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Classical extubation technique : ETT was removed with continuous endotracheal suction
Arm Title
VSPEP
Arm Type
Experimental
Arm Description
ETT was removed with APL valve set to 20cmH2O
Arm Title
VSAIPEP
Arm Type
Experimental
Arm Description
ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room
Intervention Type
Procedure
Intervention Name(s)
positive pressure during extubation procedure
Intervention Description
positive pressure during extubation procedure
Primary Outcome Measure Information:
Title
desaturations during extubation
Description
saturation <92%
Time Frame
1 minute after extubation
Secondary Outcome Measure Information:
Title
desaturation postoperatory
Description
saturation<92%
Time Frame
5 and 30 minutes after extubation
Title
hypoxemia post operatory
Description
PaO2 <60mmHg
Time Frame
1 and 30 minutes after extubation
Title
atelectasis
Description
Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome
Time Frame
30 minutes after extubation
Title
awakening time
Description
time in seconds
Time Frame
through extubation completion, an average 2 minutes
Title
use of oxygen
Description
days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation
Time Frame
day 7
Title
post operative complications
Description
Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome
Time Frame
day 7 and day 28
Title
feasibility and acceptance of both techniques pressure positive extubation
Description
questionnaire, min = 4, max =20, higher scores mean is worse outcome
Time Frame
15 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric CIRENEI, MD
Phone
0320445962
Ext
+33
Email
cedric.cirenei@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric CIRENEI, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Does Positive Pressure Extubation Reduce Postoperative Desaturation?

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