NCT03239678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

July 30, 2017

Last Update Submit

November 28, 2022

Conditions

Anesthesia, General

Keywords

PreoxygenationOxygen Concentration

Outcome Measures

Primary Outcomes (1)

  • Safe time for apnea

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

    10 min

Secondary Outcomes (1)

  • Time needed for endotracheal intubation

    1 min

Study Arms (6)

group A

ACTIVE COMPARATOR

100% Oxygen

Drug: 100% Oxygen

group B

EXPERIMENTAL

30% Oxygen.

Drug: 30% Oxygen

group C

EXPERIMENTAL

21% Oxygen

Drug: 21% Oxygen

group D

EXPERIMENTAL

40% Oxygen

Drug: 40% Oxygen

group E

EXPERIMENTAL

60% Oxygen

Drug: 60% Oxygen

group F

EXPERIMENTAL

80% Oxygen

Drug: 80% Oxygen

Interventions

100% OxygenDRUG

Conventional preoxygenation with 100% oxygen

Also known as: 100% O2
group A
30% OxygenDRUG

preoxygenation with 30% oxygen

Also known as: 30% O2
group B
21% OxygenDRUG

preoxygenation with 21% oxygen

Also known as: 21% O2
group C
40% OxygenDRUG

preoxygenation with 40% oxygen

Also known as: 40% O2
group D
60% OxygenDRUG

preoxygenation with 60% oxygen

Also known as: 60% O2
group E
80% OxygenDRUG

preoxygenation with 80% oxygen

Also known as: 80% O2
group F

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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/㎡

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510655, China

Location

Related Publications (3)

  • 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.

    PMID: 8519574BACKGROUND

  • 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.

    PMID: 7760608BACKGROUND

  • 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.

    PMID: 12502975BACKGROUND

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Sanqing Jin, MD

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Zijia Li

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University

Study Record Dates

First Submitted

July 30, 2017

First Posted

August 4, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

CN(1)