Clinical trial NCT01323049: Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia
Official title: Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: extubation strategy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Spontaneous ventilation (air) time without desaturation after extubation (min)
timeFrame: 10 minutes
Secondary outcomes:
measure: presence/absence of a desaturation after extubation
timeFrame: 10 minutes
measure: minimum Sp02 level after extubation (%)
timeFrame: 10 minutes
measure: minimum Sp02 level after extubation (%)
timeFrame: 60 minutes
measure: presence/absence of complications
timeFrame: 60 minutes
measure: presence / absence of therapeutic maneuvers
timeFrame: 60 minutes
measure: presence/absence of any complication
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Joël L'Hermite, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.