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Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit

NCT ID: NCT04879290

Last Updated: 2021-11-03

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

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2021-08-16

Brief Summary

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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

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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.

Conditions

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Anesthesia Atelectasis Postoperative Complications Hypoxemia Hyperoxia

Keywords

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Post-anesthesia care unit Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group FiO2=1

FiO2 = 1 (100%) 10mn before emergence of general anesthesia

Group Type ACTIVE_COMPARATOR

FiO2 1

Intervention Type OTHER

Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 1 (100%)

Intervention Group FiO2 0.5

Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia

Group Type EXPERIMENTAL

FiO2 0.5

Intervention Type OTHER

Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 0.5 (50%)

Interventions

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FiO2 0.5

Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 0.5 (50%)

Intervention Type OTHER

FiO2 1

Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 1 (100%)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr KAMGA TOTOUOM, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiologist

Pr HANOUZ, PhD

Role: STUDY_DIRECTOR

Anesthesiologist

Dr BOUTROS, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiologist

Locations

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University Hospital, Caen

Caen, , France

Site Status

Countries

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France

Other Identifiers

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19-172

Identifier Type: -

Identifier Source: org_study_id