Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion

Not Applicable

Recruiting

• Conditions: Pulmonary Disease
• Interventions: Procedure: low FiO2; Procedure: high FiO2

• Registration Number: NCT06202586
• Lead Sponsor: RenJi Hospital

Brief Summary

To evaluate the effect of 80% inspiratory oxygen fraction (FiO2) and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy.

Detailed Description

Postoperative pulmonary complications (PPCs) account for the highest proportion (about 84%) among all the factors leading to death in thoracic surgery. High FiO2 was used in perioperative period. However, there is increasing evidence that high FiO2 in non-thoracic surgery can increase respiratory related adverse events and even mortality. The guideline also suggests that low FiO2 (30-50%) during surgery while ensuring moderate level of oxygenation would be more beneficial to the prognosis of patients. Whereas, the selection of oxygen concentration in thoracic surgery is still unclear, especially which oxygen concentration ventilation is more beneficial to reduce PPCs after pulmonary reexpansion. Strict randomized controlled clinical studies are urgently needed to verify the differences in the incidence of PPCs in patients with different oxygen concentration ventilation strategies. The study aim is to evaluate the effect of 80% FiO2 and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy, and to provide clinical basis for optimizing perioperative management of thoracic surgery and effectively reducing the occurrence of perioperative pulmonary complications

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Last Update Submitted: 2024-01-01
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Study Start: 2024-02-01
• Primary Completion: 2025-08-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Elective thoracic surgery: lung surgery, esophageal surgery, mediastinal surgery, etc.; 2. One-lung ventilation: double lumen bronchial cannula or occluder is used for isolation of one lung; 3, American Society of Anesthesiology (ASA) grade I ~ III; 4, 18 years ≤ age < 80 years; 5. Estimated operation time ≥2 hours; 6. Agree to participate and sign the informed consent.

Exclusion Criteria

1. Severe lung infection occurs within 1 month;

2. Coronary heart disease or heart failure occurs within 2 or 3 months;

3. Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI>35 kg/m2;

4. Pregnant women; 7. Preoperative Hb<70g/L or haematocrit<30%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Received low FiO2	low FiO2	Patients undergoing elective thoracic surgery were treated with 30% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative.
Received high FiO2	high FiO2	Patients undergoing elective thoracic surgery were treated with 80% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative.

Primary Outcome Measures

Name	Time	Method
The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days	7 postoperative days	The incidence of a composite of PPCs within the first 7 postoperative days evaluated by established criteria

Secondary Outcome Measures

Name	Time	Method
Oxygenation index	after extubation and 1 day after surgery	The oxygenation index after extubation and 1 day after surgery was recorded
Length of stay in ICU	immediately after surgery	Length of stay in ICU (patients admitted to ICU due to bed turnover are not counted)
PPCs related mortality	30 postoperative days	PPCs related mortality within 30 days after surgery was calculated
Secondary diagnosis of PPCs	7 postoperative days	PPCs were defined by established criteria and included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis
Grading of PPCs	7 postoperative days	Grading of PPCs evaluated by Clavien-Dindo classification
Grading of surgical complications	30 postoperative days	The surgical complications were classified with the Clavien-Dindo classification from grade 0 (no complication) to grade V (death)
Extubation time	immediately after surgery	The time from the end of surgery to extubation was calculated
Duration of hospitalization	immediately after admission	Duration of hospitalization were recorded
Incidence of respiratory system related symptoms	30 postoperative days	Incidence of respiratory system related symptoms within 30 days after surgery was calculated
All-cause mortality	30 postoperative days	All-cause mortality within 30 days after surgery was calculated

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China