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

NCT06202586 | Recruiting DMC

• 1 other identifier: The DOC-PCT trial
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease

Keywords

postoperative pulmonary complications; thoracic surgery; inspiratory oxygen fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Secondary diagnosis of PPCs

  7 postoperative days

• Grading of PPCs

  7 postoperative days

• Grading of surgical complications

  30 postoperative days

• Extubation time

  immediately after surgery

• Oxygenation index

  after extubation and 1 day after surgery

Study Arms (2)

Received low FiO2

EXPERIMENTAL

Patients undergoing elective thoracic surgery were treated with 30% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative.

Procedure: low FiO2

Received high FiO2

ACTIVE COMPARATOR

Patients undergoing elective thoracic surgery were treated with 80% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative.

Procedure: high FiO2

Interventions

low FiO2 PROCEDURE

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.

Received low FiO2

high FiO2 PROCEDURE

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.

Received high FiO2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Severe lung infection occurs within 1 month;
• Coronary heart disease or heart failure occurs within 2 or 3 months;
• Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI\>35 kg/m2;
• \. Pregnant women; 7. Preoperative Hb\<70g/L or haematocrit\<30%.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Wang Xiaojing, M.D.

  Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Wang Xiaojing, M.D.

CONTACT

+8613764152169; yoyowxj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: February 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: April 30, 2026
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (1)