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NCT Number: NCT07293286

Effect of Different Oxygen Concentrations Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit

Before extubation during the anesthesia recovery period, 100% oxygen is routinely inhaled to increase the oxygen reserves, maximizing the time window for anesthesiologists to adjust strategies when they encounter hypoxemia after extubation.

However, even inhaling a short period of pure oxygen can cause absorptive atelectasis, and may even impair the effectiveness of intraoperative protective ventilation measures continuing to post-operative period. The purpose of this study is to determine whether 30% oxygen before extubation after abdominal surgery could reduce hypoxemia incidence after extubation during the recovery period or not, compared to 100% oxygen. 590 patients scheduled to abdominal surgeries, will be randomly assigned to receive 30% or 100% oxygen concentration from the end of surgery to extubation after general anesthesia in the post-anesthesia care unit. The incidence of hypoxemia (SpO2 < 90%) from extubation to leaving the post-anesthesia care unit (PACU) is the primary outcome.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-65 years old, scheduled for elective abdominal surgery in general anesthesia with endotracheal intubation; ASA I-III grade; cardiac function 1-2 grade; 18 kg/m2 < BMI < 28 kg/m2; Preoperative SpO2 ≥ 94% without oxygen supplementation at rest; pre-anesthesia assessment shows no difficult airway, no difficulty with mask ventilation, no difficulty in intubation during tracheal insertion, and no difficulty in extubation as expected.

Exclusion criteria

  • Respiratory infection recently, or atelectasis, inflammation, fibrosis, or pleural effusion by chest CT preoperatively.

History thoracic surgery and fractures of the sternum or ribs, chest deformity, difficulty in raising both upper limbs, or scoliosis.

High risk of reflux aspiration. Severe hepatic or renal dysfunction (e.g., Child-Pugh class C liver disease, or requiring dialysis).

Limb movement disorders. Mask ventilation or intubation difficulty during anesthesia induction. Occurrence of severe allergy, massive bleeding, suspected pulmonary embolism, pulmonary edema, myocardial injury, or cardiopulmonary arrest during surgery.

Currently participating in other clinical studies, which may have an impact on this study.

Inability to cooperate well for mental disorder, or hypophrenia.

Treatment and study plan

100% oxygen concentration inhaled

Other

Oxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 100%.

30% oxygen concentration inhaled

Other

Oxygen concentration inhaled from the end of surgery to tracheal extubation after general anesthesia in the recovery period is 30%.

Primary outcomes

  1. Incidence of hypoxemia

    Time frame: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit

Secondary outcomes

  1. Incidence of post operative pulmonary-related complications

    Time frame: Within 7 days after surgery

  2. Incidence of severe hypoxemia

    Time frame: At the day of surgery from tracheal extubation to leaving the post-anesthesia care unit

  3. Arterial partial pressure of oxygen (PaO2)

    Time frame: At the day of surgery after tracheal extubation in the post-anesthesia care unit

  4. Score of lung ultrasound

    Time frame: At the day of surgery after tracheal extubation in the post-anesthesia care unit

    The score of lung ultrasound ranges from 0 to 36, and a higher score means a worse ventilation.

  5. Area of atelectasis shown on chest CT

    Time frame: At the day of surgery after tracheal extubation

  6. Number of patients unplanned transfers to the ICU

    Time frame: 30 days after surgery

  7. Length of postoperative stay

    Time frame: At hospital discharge

  8. Number of patients return to the hospital after discharge

    Time frame: 30 days after surgery

  9. Number of deaths

    Time frame: 30 days after surgery

  10. Number of patients with important organ disfunction after surgery, including arrhythmia, acute myocardial injury, heart failure, renal function injury, liver function injury, and cerebrovascular accident.

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Effect of Different Oxygen Concentrations During the Recovery Period Before Extubation After General Anesthesia on Hypoxemia After Extubation in Post-anesthesia Care Unit

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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