Clinical trial NCT04879290: Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit
Official title: Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Atelectasis
Postoperative Complications
Hypoxemia
Hyperoxia
Keywords: Post-anesthesia care unit
Extubation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.

Detailed description: During pre-anesthesia visit, eligible patients receive oral and written information of the study and potential risks.

In the operating room all patients giving a written informed consent will undergo at the end of surgery a screening to determine eligibility for study entry.

Before emergence from general anesthesia, patients who meet the eligibility requirements will be randomized in a open label manner to receive a 0.5 or 1 FiO2.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing general anesthesia, with invasive mechanical ventilation including an airway device (supraglottic airway device or tracheal tube) at their arrival in PACU.
* ASA physical status classification 1, 2, or 3 stabilized.
* Surgery performed in emergency operating room department including vascular, digestive, urological and minor trauma surgery or surgery performed in head and neck anesthesia pole block including anterior cervical spine, lumbar disc herniation, cranioplasty, nerve stimulator, vertebroplasty, narrow lumbar canal, simple arthrodesis (less than or equal to two stages), otological, ophthalmological and skin surgery.

Exclusion Criteria:

* Per-operative hemodynamic instability.
* Patients with a BMI greater than 35.
* Patients classified as difficult to intubate and / or ventilate.
* Heavy surgeries (operating time greater than 4 hours).
* Patient requiring postoperative non invasive mechanical ventilation
* Patients with diagnosed COPD
* SPO2 in room air \< 96% before the intervention.
* Any patient under guardianship.
* Pre-operative and / or intra-operative morphine intake.
* Surgical management of the upper airways (ex : tonsillectomy)
* Pregnant and lactating women.

Primary outcomes:
measure: Decrease of oxygen saturation
timeFrame: Duration of stay in post-anesthesia care unit, approximately one hour
Secondary outcomes:
measure: Duration of emergence
timeFrame: Up to one hour
measure: Primary Outcome Timing
timeFrame: Up to one hour
measure: Number of risk factors
timeFrame: One hour
measure: Majored decrease of oxygen saturation
timeFrame: One hour
measure: Corrective measures
timeFrame: One hour
measure: PACU length of stay
timeFrame: One hour
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital, Caen
Study officials:
affiliation: Anesthesiologist
name: Dr KAMGA TOTOUOM, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiologist
name: Pr HANOUZ, PhD
role: STUDY_DIRECTOR
affiliation: Anesthesiologist
name: Dr BOUTROS, MD
role: PRINCIPAL_INVESTIGATOR
References: