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Completed

NCT Number: NCT03239678

Safe Time for Apnea After Preoxygenation

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/㎡

Treatment and study plan

100% Oxygen

Drug

Conventional preoxygenation with 100% oxygen

Other names: 100% O2

30% Oxygen

Drug

preoxygenation with 30% oxygen

Other names: 30% O2

21% Oxygen

Drug

preoxygenation with 21% oxygen

Other names: 21% O2

40% Oxygen

Drug

preoxygenation with 40% oxygen

Other names: 40% O2

60% Oxygen

Drug

preoxygenation with 60% oxygen

Other names: 60% O2

80% Oxygen

Drug

preoxygenation with 80% oxygen

Other names: 80% O2

Primary outcomes

  1. Safe time for apnea

    Time frame: 10 min

    Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.

Secondary outcomes

  1. Time needed for endotracheal intubation

    Time frame: 1 min

    Time from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Safe Time for Apnea After Preoxygenation With Different Oxygen Concentration During the Induction of General Anesthesia

Acronym: STAP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2017
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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