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CompletedNCT03239678STAPUpdated Nov 29, 2022

Safe Time for Apnea After Preoxygenation

An interventional study of 100% Oxygen and 30% Oxygen in Anesthesia, General, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

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Conditions studied

  • Anesthesia, General

Keywords

  • Preoxygenation
  • Oxygen Concentration
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In context

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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/㎡
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    group A

    100% Oxygen

    Drug: 100% Oxygen

  • Experimental
    group B

    30% Oxygen.

    Drug: 30% Oxygen

  • Experimental
    group C

    21% Oxygen

    Drug: 21% Oxygen

  • Experimental
    group D

    40% Oxygen

    Drug: 40% Oxygen

  • Experimental
    group E

    60% Oxygen

    Drug: 60% Oxygen

  • Experimental
    group F

    80% Oxygen

    Drug: 80% Oxygen

Interventions

  • Drug100% Oxygen

    Conventional preoxygenation with 100% oxygen

    Also known as: 100% O2

  • Drug30% Oxygen

    preoxygenation with 30% oxygen

    Also known as: 30% O2

  • Drug21% Oxygen

    preoxygenation with 21% oxygen

    Also known as: 21% O2

  • Drug40% Oxygen

    preoxygenation with 40% oxygen

    Also known as: 40% O2

  • Drug60% Oxygen

    preoxygenation with 60% oxygen

    Also known as: 60% O2

  • Drug80% Oxygen

    preoxygenation with 80% oxygen

    Also known as: 80% O2

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What researchers measure

Primary outcomes

  1. Safe time for apnea

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

    Time frame: 10 min

Secondary outcomes

  1. Time needed for endotracheal intubation

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

    Time frame: 1 min

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Study locations

1 site
  • Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
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References and documents

Publications

  • Lundquist H, Hedenstierna G, Strandberg A, Tokics L, Brismar B. CT-assessment of dependent lung densities in man during general anaesthesia. Acta Radiol. 1995 Nov;36(6):626-32. PubMed 8519574 ↗
  • Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3. PubMed 7760608 ↗
  • Edmark L, Kostova-Aherdan K, Enlund M, Hedenstierna G. Optimal oxygen concentration during induction of general anesthesia. Anesthesiology. 2003 Jan;98(1):28-33. doi: 10.1097/00000542-200301000-00008. PubMed 12502975 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03239678
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
Zijia Li (Principal Investigator, Department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Aug 4, 2017
Start date
Aug 1, 2017
Primary completion
Dec 30, 2017
Completion
Dec 30, 2017
Last update
Nov 29, 2022

Study contacts

Sanqing Jin, MD
principal investigator · Sixth Affiliated Hospital, Sun Yat-sen University
Zijia Li
principal investigator · Sixth Affiliated Hospital, Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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