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

NCT07293286 | Not Yet Recruiting DMC

• 1 other identifier: 2025ZSLYSC-630
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia

Keywords

hypoxemia; oxygen concentration; atelectasis

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxemia

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

Secondary Outcomes (10)

• Incidence of post operative pulmonary-related complications

  Within 7 days after surgery

• Incidence of severe hypoxemia

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

• Arterial partial pressure of oxygen (PaO2)

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

• Score of lung ultrasound

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

• Area of atelectasis shown on chest CT

  At the day of surgery after tracheal extubation

Study Arms (2)

Control group : 100% oxygen concentration

ACTIVE COMPARATOR

Patients will inhale 100% oxygen from the end of surgery to tracheal extubation in the recovery period.

Other: 100% oxygen concentration inhaled

Experimental group: 30% oxygen concentration

EXPERIMENTAL

Patients will inhale 30% oxygen from the end of surgery to extubation in the recovery period.

Other: 30% oxygen concentration inhaled

Interventions

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%.

Control group : 100% oxygen concentration

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%.

Experimental group: 30% oxygen concentration

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hypoxia; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sanqing Jin

CONTACT

+86 13719366863; sanqingjin@hotmail.com

Yanna Pi

CONTACT

+86 18819186153; piyanna@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 19, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)