Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit (EXTUBO2)

Caen University Hospital

Status: Completed

Conditions: Postoperative Complications; Hyperoxia; Atelectasis; Hypoxemia; Anesthesia

Treatments: Other: FiO2 0.5; Other: FiO2 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04879290

19-172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Control Group FiO2=1

Active Comparator group

Description:

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

Treatment:

Other: FiO2 1

Intervention Group FiO2 0.5

Experimental group

Description:

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

Treatment:

Other: FiO2 0.5