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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07293286
Enrollment
590
Registered
2025-12-19
Start date
2025-12-30
Completion date
2026-06-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia

Keywords

hypoxemia, oxygen concentration, atelectasis

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.

Interventions

OTHER100% oxygen concentration inhaled

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

OTHER30% oxygen concentration inhaled

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

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemiaAt the day of surgery from tracheal extubation to leaving the post-anesthesia care unit

Secondary

MeasureTime frameDescription
Incidence of severe hypoxemiaAt 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 ultrasoundAt the day of surgery after tracheal extubation in the post-anesthesia care unitThe score of lung ultrasound ranges from 0 to 36, and a higher score means a worse ventilation.
Area of atelectasis shown on chest CTAt the day of surgery after tracheal extubation
Incidence of post operative pulmonary-related complicationsWithin 7 days after surgery
Length of postoperative stayAt hospital discharge
Number of patients return to the hospital after discharge30 days after surgery
Number of deaths30 days after surgery
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.30 days after surgery
Number of patients unplanned transfers to the ICU30 days after surgery

Countries

China

Contacts

Primary ContactSanqing Jin
sanqingjin@hotmail.com+86 13719366863
Backup ContactYanna Pi
piyanna@126.com+86 18819186153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026