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Lower Inspiratory Oxygen Fraction for Preoxygenation

NCT03665259 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2019-02-27

No results posted yet for this study

Summary

During the induction period of general anesthesia, surgical patients are inevitably experienced a short period of apnea for endotracheal intubation or other airway manipulation. In order to minimize the risks of hypoxemia during the establishment of artificial airway, pure oxygen (FiO2=100%) is commonly applied to the patients throughout the preoxygenation and induction period. However, high concentration of oxygen therapy has been shown to result in hyperoxemia and substantial oxygen exposure during perioperative period or critical care. There is currently no clinical evidence indicating that preoxygenation with a lower oxygen partial pressure (such as FiO2=60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. The findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspired oxygen concentrations on the general postoperative outcomes during general anesthesia.

Conditions

  • Intraoperative Complications
  • Respiratory Complication
  • Oxygen Toxicity
  • Oxygen Deficiency
  • Anesthesia

Interventions

PROCEDURE

Pure oxygen group

pre-oxygenation with 100% oxygen during induction of anesthesia

PROCEDURE

Lower oxygen group

Pre-oxygenation with 60% oxygen during induction of anesthesia

Sponsors & Collaborators

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Chen-Fuh Lam, MD, PhD · E-DA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03665259 on ClinicalTrials.gov