Safe Time for Apnea After Preoxygenation

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: 30% Oxygen; Drug: 21% Oxygen; Drug: 40% Oxygen; Drug: 100% Oxygen; Drug: 60% Oxygen; Drug: 80% Oxygen

• Registration Number: NCT03239678
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

The use of 100% oxygen during the induction of general anesthesia is always preferable to have enough time to secure the airway by endotracheal intubation, because preoxygenation with a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen concentration during preoxygenation might prevent the formation of atelectasis. There is still no clear conclusion about the best oxygen concentration for preoxygenation. Our study is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen by the safe time for apnea during the induction of general anesthesia.

Detailed Description

We decide to add 3 groups (80%, 60%, and 40% oxygen) in our study to fully evaluate the safety of preoxygenation with different oxygen concentration.

Zijia Li 2018.3.2

Study Timeline

• Study First Submitted: 2017-07-30
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-04
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Nonsmoking patients aged 18 years to 60 years
• Undergoing general anesthesia for elective surgery
• Pulse oxygen saturation ≥95% when breathing air quietly in bed
• American Society of Anesthesiologists(ASA) physical status class I-II
• Informed consent can be obtained

Exclusion Criteria

• A suspected difficult airway
• Be allergic to midazolam, propofol , fentanyl or Cisatracurium
• Severe disease of respiratory system or cardiovascular system,or obstruction of the digestive tract
• Oxygen reserve is suspected low,or patient who does not tolerate hypoxemia well
• A history of mental disorder or patient who can not collaborate well
• Body mass index more than 30 kg/㎡

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	30% Oxygen	30% Oxygen.
group C	21% Oxygen	21% Oxygen
group D	40% Oxygen	40% Oxygen
group A	100% Oxygen	100% Oxygen
group E	60% Oxygen	60% Oxygen
group F	80% Oxygen	80% Oxygen

Primary Outcome Measures

Name	Time	Method
Safe time for apnea	10 min	Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.

Secondary Outcome Measures

Name	Time	Method
Time needed for endotracheal intubation	1 min	Time from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.

Trial Locations

Locations (1)

Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China