Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243146
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-01-28
Brief Title:
Titration of Inspired Oxygen to Decrease the Incidence of Postoperative Pulmonary Complications
Sponsor:
Sichuan Provincial Peoples Hospital
Organization:
Sichuan Provincial Peoples Hospital
Study Overview
Official Title:
Titration of Inspired Oxygen During One-lung Ventilation to Decrease the Incidence of Postoperative Pulmonary Complications a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hypoxiahyperxemia oxygenation index PaO2FiO2 and intrapulmonary shunt rate QsQt 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
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 hypoxiahyperxemia oxygenation index PaO2FiO2 and intrapulmonary shunt rate QsQt 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
Detailed 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 OLVElderly 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 hypoxiahyperxemia oxygenation index PaO2FiO2 and intrapulmonary shunt rate QsQt 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
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 hypoxiahyperxemia oxygenation index PaO2FiO2 and intrapulmonary shunt rate QsQt 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None