Safe Time for Apnea After Preoxygenation

NCT ID: NCT03239678

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-12-30

Brief Summary

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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

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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

Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group A

100% Oxygen

Group Type ACTIVE_COMPARATOR

100% Oxygen

Intervention Type DRUG

Conventional preoxygenation with 100% oxygen

group B

30% Oxygen.

Group Type EXPERIMENTAL

30% Oxygen

Intervention Type DRUG

preoxygenation with 30% oxygen

group C

21% Oxygen

Group Type EXPERIMENTAL

21% Oxygen

Intervention Type DRUG

preoxygenation with 21% oxygen

group D

40% Oxygen

Group Type EXPERIMENTAL

40% Oxygen

Intervention Type DRUG

preoxygenation with 40% oxygen

group E

60% Oxygen

Group Type EXPERIMENTAL

60% Oxygen

Intervention Type DRUG

preoxygenation with 60% oxygen

group F

80% Oxygen

Group Type EXPERIMENTAL

80% Oxygen

Intervention Type DRUG

preoxygenation with 80% oxygen

Interventions

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100% Oxygen

Conventional preoxygenation with 100% oxygen

Intervention Type DRUG

30% Oxygen

preoxygenation with 30% oxygen

Intervention Type DRUG

21% Oxygen

preoxygenation with 21% oxygen

Intervention Type DRUG

40% Oxygen

preoxygenation with 40% oxygen

Intervention Type DRUG

60% Oxygen

preoxygenation with 60% oxygen

Intervention Type DRUG

80% Oxygen

preoxygenation with 80% oxygen

Intervention Type DRUG

Other Intervention Names

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100% O2 30% O2 21% O2 40% O2 60% O2 80% O2

Eligibility Criteria

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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/㎡
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zijia Li

Principal Investigator, Department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanqing Jin, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Zijia Li

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 8519574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7760608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12502975 (View on PubMed)

Other Identifiers

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2017ZSLYEC-022

Identifier Type: -

Identifier Source: org_study_id

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