Clinical trial NCT06202586: Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion
Official title: Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion Following One-lung Ventilation in Thoracic Surgery（DOC-PCT Trial）- A Prospective Randomized Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease
Keywords: postoperative pulmonary complications
thoracic surgery
inspiratory oxygen fraction
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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;

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

Primary outcomes:
measure: The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days
timeFrame: 7 postoperative days
Secondary outcomes:
measure: Secondary diagnosis of PPCs
timeFrame: 7 postoperative days
measure: Grading of PPCs
timeFrame: 7 postoperative days
measure: Grading of surgical complications
timeFrame: 30 postoperative days
measure: Extubation time
timeFrame: immediately after surgery
measure: Oxygenation index
timeFrame: after extubation and 1 day after surgery
measure: Length of stay in ICU
timeFrame: immediately after surgery
measure: Duration of hospitalization
timeFrame: immediately after admission
measure: Incidence of respiratory system related symptoms
timeFrame: 30 postoperative days
measure: All-cause mortality
timeFrame: 30 postoperative days
measure: PPCs related mortality
timeFrame: 30 postoperative days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Wang Xiaojing, M.D.
role: STUDY_DIRECTOR
References: