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Completed

NCT Number: NCT01323049

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Positive pressure extubation

Procedure

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

Aspiration/suction extubation

Procedure

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

Primary outcomes

  1. Spontaneous ventilation (air) time without desaturation after extubation (min)

    Time frame: 10 minutes

    desaturation is defined as an SpO2< 92%

Secondary outcomes

  1. presence/absence of a desaturation after extubation

    Time frame: 10 minutes

    desaturation is defined as an SpO2<92%

  2. minimum Sp02 level after extubation (%)

    Time frame: 10 minutes

  3. minimum Sp02 level after extubation (%)

    Time frame: 60 minutes

  4. presence/absence of complications

    Time frame: 60 minutes

    coughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour

  5. presence / absence of therapeutic maneuvers

    Time frame: 60 minutes

    includes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour

  6. presence/absence of any complication

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 25, 2011
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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