Lower Inspiratory Oxygen Fraction for Preoxygenation

NCT03665259 | Terminated DMC

• 1 other identifier: EMRP15107N
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oxygen; Perioperative medicine; General anesthesia; Preoxygenation

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxemia

  The definition of hypoxemia is the measurement of peripheral oxygen saturation (sPO2) lower than \< 92%. Induction phase of anesthesia is defined as the time frame from preoxygenation before intravenous administration of anesthetics to successful establishment of an endotracheal tube.

  Within 30 minutes after induction of anesthesia

Secondary Outcomes (6)

• Development of acute respiratory distress syndrome (ARDS)

  Within 7 days after surgery

• Development of atelectasis

  Within 7 days after surgery

• Development of pneumonia

  Within 7 days after surgery

• Development of surgical site infection (SSI)

  Within 7 days after surgery

• Development of severe postoperative pain

  Within 7 days after surgery

Study Arms (2)

Pure oxygen group

ACTIVE COMPARATOR

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

Procedure: Pure oxygen group

Lower oxygen group

EXPERIMENTAL

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

Procedure: Lower oxygen group

Interventions

Pure oxygen group PROCEDURE

pre-oxygenation with 100% oxygen during induction of anesthesia

Pure oxygen group

Lower oxygen group PROCEDURE

Pre-oxygenation with 60% oxygen during induction of anesthesia

Lower oxygen group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient who is scheduled for an elective surgery and required for general anesthesia with endotracheal intubation.
• Age of the patient is between 20 and 65 years old.
• Patient's American Society of Anesthesiologists (ASA) Physical Status is I- III.

You may not qualify if:

• Patients who:
• Have difficult airway for ventilation or intubation.
• Have severe lung disease (including any acute respiratory infection).
• Had past history of coronary artery disease or myocardial infarction.
• Have severe heart failure (NYHA Fc ≥III).
• Have liver cirrhosis (Child-Pugh's score ≥B).
• Have acute or chronic kidney disease (Creatinine ≥2 mg/dl).
• Have severe anemia (hemoglobin ≤8 mg /dl).
• Have a body mass index (BMI) ≥35.
• Are currently pregnant.
• Have inadequate fasting time, intestinal obstruction or severe gastroesophageal reflux.
• Scheduled for an emergency surgery, cardiac surgery, craniotomy, or pulmonary surgery.
• Have mental incapacitant, confusion, dementia, mental retardation, or are unable to complete the consent independently.
• Refuse to participate in this study.

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

E-Da Hospital

Yanchao, Kaohsiung, 824, Taiwan

Location

MeSH Terms

Conditions

Intraoperative Complications; Hypoxia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Chen-Fuh Lam, MD, PhD

  E-DA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthetist who in-charge of the induction of anesthesia is aware of the treatment oxygen concentration. The patient is unaware of oxygen concentration during the induction of anesthesia. The outcomes assessors is unaware of the concentration of oxygen treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: pre-oxygenation with 100% oxygen during induction of anesthesia Group 2: pre-oxygenation with 60% oxygen during induction of anesthesia

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 11, 2018
• Study Start: November 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 27, 2019

Record last verified: 2018-09

Locations

TW (1)