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

Unrecognized Condition Clinical Trial

Official title: Titration of Inspired Oxygen During One-lung Ventilation to Decrease the Incidence of Postoperative Pulmonary Complications: a Randomized Controlled Trial

Status Recruiting

Clinical Trial 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, oxygenation index (PaO2/FiO2) and intrapulmonary shunt rate (Qs/Qt), oxidative stress indicators, 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.

Clinical Trial Description

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).Elderly patients with decreased lung function are prone to hypoxemia, which is also a high-risk group for postoperative PPCs induced by hyperxemia, with a dual risk of hypoxia and hyperoxia. Perioperative respiratory management is more challenging. Therefore, it is necessary to explore more suitable oxygen supply methods for patients during OLV.

We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. All patients will be intubated with a left bronchial tube using visual laryngoscopy. Fiberoptic bronchoscopy will be used to comfirm the optimal localization of the tube. Lung protective ventilation strategy will be used during ventilation. Before OLV, FiO2 of 100% will be used. 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. After OLV, FiO2 of 50% will be used. The incidence of postoperative PPCs, hypoxia/hyperxemia, oxygenation index (PaO2/FiO2) and intrapulmonary shunt rate (Qs/Qt), oxidative stress indicators, and prolonged hospital stay will be compared between 2 groups. The effectiveness and safety of titrating inhaled oxygen concentration during OLV will be elevated. ;

Related Conditions & MeSH terms

• Respiratory Aspiration
• Unrecognized Condition

• NCT number: NCT06243146
• Study type: Interventional
• Source: Sichuan Provincial People's Hospital
• Contact: Chenghong Wang, MD
• Phone: 13488943096
• Email: 931405180@qq.com
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2024
• Completion date: December 31, 2025