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

Anesthesia Clinical Trial

— EXTUBO2  

Official title:

Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879290
• Other study ID #: 19-172
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Atelectasis
• Hyperoxia
• Hypoxemia
• Hypoxia
• Postoperative Complications
• Pulmonary Atelectasis

Intervention

Other:
• 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%)
• 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%)

Locations

Country	Name	City	State
France	University Hospital, Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of oxygen saturation	Proportions of patients that present a decrease of 4 points of peripheral capillary oxygen saturation (SpO2) measured with pulse oximetry after extubation compared to their baseline room air SpO2	Duration of stay in post-anesthesia care unit, approximately one hour
Secondary	Duration of emergence	Elapsed Time between cessation of sedation and extubation (minutes)	Up to one hour
Secondary	Primary Outcome Timing	Elapsed time between extubation and decrease of oxygen saturation (minutes)	Up to one hour
Secondary	Number of risk factors	Number of factors associated with episodes of hypoxemia : bronchospasm, bronchial congestion (profuse secretions with the need to aspirate the patient several times), loss of upper airway muscle tonus (fall of the tongue).	One hour
Secondary	Majored decrease of oxygen saturation	Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2	One hour
Secondary	Corrective measures	Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.	One hour
Secondary	PACU length of stay	Length of stay in post-anesthesia care unit	One hour