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

Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202586
• Other study ID #: The DOC-PCT trial
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: January 2024
• Source: RenJi Hospital
• Contact: Wang Xiaojing, M.D.
• Phone: +8613764152169
• Email: yoyowxj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Procedure:
• low FiO2
FiO2 was 100% in two-lung ventilation during anesthesia induction and one-lung ventilation stage intraoperative. FiO2 was 30% in two-lung ventilation after pulmonary reexpansion. During 2 hours after extubation, oxygen was administered through a non-reabsorption mask (high concentration oxygen mask; Intersurgical Ltd, Wokingham, UK) with a respiratory sac in the post anesthesia care unit (PACU), FiO2 was 30% (2L oxygen +14L air per minute). If the subjects who need to be admitted to the intensive care unit (ICU) fail to resuscitate the extubation within a short time after surgery due to their condition and require prolonged respiratory support, FiO2 should be adjusted to 30% 2 hours after admission to the ICU, and respiratory support according to the routine ventilation strategy of ICU should be provided 2 hours later.
• high FiO2
FiO2 was 100% in two-lung ventilation during anesthesia induction and one-lung ventilation stage intraoperative. FiO2 was 80% in two-lung ventilation after pulmonary reexpansion. During 2 hours after extubation, oxygen was administered through a non-reabsorption mask (high concentration oxygen mask; Intersurgical Ltd, Wokingham, UK) with a respiratory sac in the post anesthesia care unit (PACU), FiO2 was 80% (14L oxygen +2L air per minute). If the subjects who need to be admitted to the intensive care unit (ICU) fail to resuscitate the extubation within a short time after surgery due to their condition and require prolonged respiratory support, FiO2 should be adjusted to 80% 2 hours after admission to the ICU, and respiratory support according to the routine ventilation strategy of ICU should be provided 2 hours later.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

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