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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01323049
Enrollment
68
Registered
2011-03-25
Start date
2012-03-31
Completion date
2014-02-25
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

extubation strategy

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.

Interventions

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

PROCEDUREAspiration/suction extubation

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Spontaneous ventilation (air) time without desaturation after extubation (min)10 minutesdesaturation is defined as an SpO2\< 92%

Secondary

MeasureTime frameDescription
presence/absence of a desaturation after extubation10 minutesdesaturation is defined as an SpO2\<92%
minimum Sp02 level after extubation (%)10 minutes
presence/absence of complications60 minutescoughing, airway obstruction, laryngospasm, desaturation, apnea, vomiting in the first hour
presence / absence of therapeutic maneuvers60 minutesincludes oxygen therapy (or bezel ventimasque), Guedel airway, mask assistance, re-intubation during the first hour
presence/absence of any complication60 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026