Lower Inspiratory Oxygen Fraction for Preoxygenation

NCT ID: NCT03665259

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-01-31

Brief 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.

Detailed Description

The administration of 100% oxygen for 3-5 minutes may replace the nitrogen content in the lung cavity (de-nitrogenation) with higher alveolar concentrations of oxygen (greater then 95%). Elevation of oxygen reserve in the lung and oxygen partial pressure in the blood circulation may thus delay the development of hypoxemia (oxygen desaturation; defined as the tissue oxygen saturation below 90%) up to 10 minutes after apnea.

On the other hand, there is currently no clinical evidence indicating that preoxygenation with lower oxygen partial pressures (i.e. FiO2= 50-60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. Most recently, two elegant large-scale clinical trials reported that the supplement of oxygen to patients with acute myocardial infarction or acute ischemic stroke did not provide any clinically beneficial effects in the prognosis of diseases. The results of these two important trials did not support the routine supplement of oxygen in these acute diseases. In addition, high concentrations of oxygen therapy are potentially deleterious, as oxygen toxicity may result in direct tracheobronchial and alveolar damage, absorption atelectasis (lung tissue collapse) and central nervous system toxicity. In cellular levels, hyperoxia increases the production of reactive oxygen species, such as the superoxide anion, the hydroxyl radical, and hydrogen peroxide, which in turn may cause cellular apoptosis and inflammatory response. Therefore, oxygen therapy in clinical settings has been recognized as a two-edged sword and excessive oxygen supplement should be guided closely for its potential toxicity.

Currently, there is no clinical evidence that supports the routine administration of 100% oxygen prior to intubation is essential or beneficial. In the contrary, it also remains undetermined if lower fractions of inspiratory oxygen during the induction period of anesthesia may attenuate lung injury or other cellular damage derived from the oxygen toxicity. Therefore, 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 inspiratory oxygen concentrations on the general postoperative outcomes after general anesthesia.

This is a randomized, open-label, observer-blind and non-inferiority clinical trial.

The research model of study is two-group parallel interventional study. The control group is preoxygenation with 100% oxygen during the induction phase of anesthesia; the experimental group is preoxygenation with 60% oxygen during the induction phase of anesthesia. The anesthetists in-charge are not blinded to the concentrations of oxygen use during induction of anesthesia, but the persons who collected study data will be unaware of the treatment. Block randomization will be generated using a generator software and the assignment of treatment will be sealed in the envelops.

This study anticipates in enrolling 1500 participants.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pure oxygen group

The patients receive 100% oxygen therapy during the induction phase of induction

Group Type: ACTIVE_COMPARATOR

Pure oxygen group

Intervention Type: PROCEDURE

pre-oxygenation with 100% oxygen during induction of anesthesia

Lower oxygen group

The patients received 60% oxygen therapy during the induction phase of induction

Group Type: EXPERIMENTAL

Lower oxygen group

Intervention Type: PROCEDURE

Pre-oxygenation with 60% oxygen during induction of anesthesia

Interventions

Pure oxygen group

pre-oxygenation with 100% oxygen during induction of anesthesia

Intervention Type: PROCEDURE

Lower oxygen group

Pre-oxygenation with 60% oxygen during induction of anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. A patient who is scheduled for an elective surgery and required for general anesthesia with endotracheal intubation.

2. Age of the patient is between 20 and 65 years old.

3. Patient's American Society of Anesthesiologists (ASA) Physical Status is I- III.

Exclusion Criteria

Patients who:

1. Have difficult airway for ventilation or intubation.

2. Have severe lung disease (including any acute respiratory infection).

3. Had past history of coronary artery disease or myocardial infarction.

4. Have severe heart failure (NYHA Fc ≥III).

5. Have liver cirrhosis (Child-Pugh's score ≥B).

6. Have acute or chronic kidney disease (Creatinine ≥2 mg/dl).

7. Have severe anemia (hemoglobin ≤8 mg /dl).

8. Have a body mass index (BMI) ≥35.

9. Are currently pregnant.

10. Have inadequate fasting time, intestinal obstruction or severe gastroesophageal reflux.

11. Scheduled for an emergency surgery, cardiac surgery, craniotomy, or pulmonary surgery.

12. Have mental incapacitant, confusion, dementia, mental retardation, or are unable to complete the consent independently.

13. Refuse to participate in this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

E-DA Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen-Fuh Lam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

E-DA Hospital

Locations

E-Da Hospital

Yanchao, Kaohsiung, Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

EMRP15107N

Identifier Type: -

Identifier Source: org_study_id