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

NCT ID: NCT01323049

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-02-25

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Positive pressure extubation

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

Group Type ACTIVE_COMPARATOR

Positive pressure extubation

Intervention Type PROCEDURE

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

Aspiration/suction extubation

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

Group Type ACTIVE_COMPARATOR

Aspiration/suction extubation

Intervention Type PROCEDURE

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

Interventions

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Positive pressure extubation

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

Intervention Type PROCEDURE

Aspiration/suction extubation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joël L'Hermite, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 28882741 (View on PubMed)

Other Identifiers

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2011-A00051-40

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2010/JL-03

Identifier Type: -

Identifier Source: org_study_id

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