Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General
• Intervention / Treatment: Procedure: Positive pressure extubation; Procedure: Aspiration/suction extubation

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive pressure extubation; Positive pressure extubation will be used for patients waking up from general anesthesia in this group	Procedure: Positive pressure extubation; Positive pressure extubation will be used for patients waking up from general anesthesia
Active Comparator: Aspiration/suction extubation; Aspiration/suction extubation will be used for patients waking up from general anesthesia in this group	Procedure: Aspiration/suction extubation; Aspiration/suction extubation will be used for patients waking up from general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous ventilation (air) time without desaturation after extubation (min)	desaturation is defined as an SpO2< 92%	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence/absence of a desaturation after extubation	desaturation is defined as an SpO2<92%	10 minutes
minimum Sp02 level after extubation (%)		10 minutes
minimum Sp02 level after extubation (%)		60 minutes
presence/absence of complications	coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour	60 minutes
presence / absence of therapeutic maneuvers	includes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour	60 minutes
presence/absence of any complication		60 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Joël L'Hermite, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 25, 2014
• Study Completion (Actual): February 25, 2014

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimated): March 25, 2011

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: extubation strategy
• Other Study ID Numbers: LOCAL/2010/JL-03; 2011-A00051-40 (Other Identifier: ANSM)