NCT01323049

Brief Summary

The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2014

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

March 24, 2011

Last Update Submit

November 14, 2025

Conditions

Anesthesia, General

Keywords

extubation strategy

Outcome Measures

Primary Outcomes (1)

  • Spontaneous ventilation (air) time without desaturation after extubation (min)

    desaturation is defined as an SpO2\< 92%

    10 minutes

Secondary Outcomes (6)

  • presence/absence of a desaturation after extubation

    10 minutes

  • minimum Sp02 level after extubation (%)

    10 minutes

  • minimum Sp02 level after extubation (%)

    60 minutes

  • presence/absence of complications

    60 minutes

  • presence / absence of therapeutic maneuvers

    60 minutes

  • +1 more secondary outcomes

Study Arms (2)

Positive pressure extubation

ACTIVE COMPARATOR

Positive pressure extubation will be used for patients waking up from general anesthesia in this group

Procedure: Positive pressure extubation

Aspiration/suction extubation

ACTIVE COMPARATOR

Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group

Procedure: Aspiration/suction extubation

Interventions

Positive pressure extubationPROCEDURE

Positive pressure extubation will be used for patients waking up from general anesthesia

Positive pressure extubation
Aspiration/suction extubationPROCEDURE

Aspiration/suction extubation will be used for patients waking up from general anesthesia

Aspiration/suction extubation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 1 hour of follow up
  • ASA 1 to 3
  • The patient is schedules for orthopedic surgery (limbs) with general anesthesia

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  • Chronic respiratory insufficiency
  • Cardiopathy
  • Obstructive sleep apnea
  • Two or more predictive criteria for difficult mask ventilation (age \> 55 years, toothless, beard, snorer, BMI \> 26)
  • No predictive criteria for difficult intubation (SPIDS \<= 10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (1)

  • L'Hermite J, Wira O, Castelli C, de La Coussaye JE, Ripart J, Cuvillon P. Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial. Anaesth Crit Care Pain Med. 2018 Apr;37(2):147-153. doi: 10.1016/j.accpm.2017.07.005. Epub 2017 Sep 4.

    PMID: 28882741RESULT

Study Officials

  • Joël L'Hermite, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

March 1, 2012

Primary Completion

February 25, 2014

Study Completion

February 25, 2014

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations

FR(1)