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

NCT ID: NCT07293286

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoxemia

Keywords

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hypoxemia oxygen concentration atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group : 100% oxygen concentration

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

Group Type ACTIVE_COMPARATOR

100% oxygen concentration inhaled

Intervention Type OTHER

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

Experimental group: 30% oxygen concentration

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

Group Type EXPERIMENTAL

30% oxygen concentration inhaled

Intervention Type OTHER

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

Interventions

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100% oxygen concentration inhaled

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

Intervention Type OTHER

30% oxygen concentration inhaled

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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SanQing Jin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Sanqing Jin

Role: CONTACT

Phone: +86 13719366863

Email: [email protected]

Yanna Pi

Role: CONTACT

Phone: +86 18819186153

Email: [email protected]

Facility Contacts

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Sanqing Jin

Role: primary

Other Identifiers

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2025ZSLYSC-630

Identifier Type: -

Identifier Source: org_study_id