Titration of Inspired Oxygen to Decrease the Incidence of Postoperative Pulmonary Complications

NCT06243146 | Recruiting

• 1 other identifier: SPPH202311011
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk factor leading to early postoperative death. High fraction of inspired oxygen (FiO2) is an independent risk factor for PPCs, but it is difficult to achieve oxygenation while avoiding hyperxemia during one lung ventilation (OLV). We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. During OLV, titration will be used to determine the optimal FiO2 for titration group while FiO2 of 80% will be used for mechanical ventilation for control group. The incidence of postoperative PPCs, hypoxia/hyperxemia, severity level of postoperative PPC, postoperative 30 day PPC, increased hospitalization costs, and prolonged hospital stay will be observed in both groups of patients.We will evaluate the effectiveness and safety of titrating inhaled oxygen concentration in lung protection during OLV.

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complications

  postoperative pulmonary complications

  first 7 days

Study Arms (2)

Titration

EXPERIMENTAL

During OLV, FiO2 starts at 80%. Titration of inspired oxygen using blood gas analysis and SpO2 monitoring. The titration target is arterial blood gas analysis with PaO2 ≤ 150mmHg and 93% ≤ SpO2 ≤ 97%.

Other: Titration of Inspired Oxygen

Control

ACTIVE COMPARATOR

During OLV, FiO2 starts at 80% and remains until the end of OLV.

Other: Titration of Inspired Oxygen

Interventions

Titration of Inspired Oxygen OTHER

Titration of Inspired Oxygen During One-Lung Ventilation

Control; Titration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ① General anesthesia with left bronchial tube intubation; ② Age range from 18 to 80 years old; ③ 18 kg/m2 ≤ BMI ≤ 30 kg/m2; ④ ASA grade I to III; ⑤ Individuals willing to participate in research and sign an informed consent form.

You may not qualify if:

• ① CT scan indicates preoperative pulmonary infection, atelectasis, and pneumothorax; ② History of respiratory system diseases (COPD, bronchiectasis, pulmonary alveoli, interstitial lung disease, etc.); ③ Previous history of lung surgery; ④ First second forced expiratory volume/estimated value (FEV1%)\<60%; ⑤ PaO2\<60mmhg (1 mmhg=0.133 kpa) or PaO2/FiO2\<300mmhg or SpO2\<90% in the suction state; ⑥ History of acute upper respiratory tract infection, acute lung injury, acute respiratory distress syndrome, or respiratory failure within 3 months prior to surgery; ⑦ Combined heart failure (NYHA heart function grading ≥ 3); ⑧ Previous history of stroke and cerebral infarction; ⑨ Severe liver dysfunction (liver failure or Child Pugh score B or C) Chronic renal failure (glomerular filtration rate\<30 ml/min) Suffering from mental illness, etc., which is not suitable for the author; æ Individuals who have participated in other clinical trials as subjects within the three months prior to participating in the study The patient refused to participate in the study.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 641400, China

RECRUITING

Study Officials

• Peng Li, MD

  Sichuan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Chenghong Wang, MD

CONTACT

13488943096; 931405180@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: June 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)