Clinical trial

Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer

Name
20230724-2
Description
Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one lung in lateral position and ventilation with both lungs after supine position requires long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of postoperative pulmonary complications is high.
Trial arms
Trial start
2023-09-06
Estimated PCD
2025-09-30
Trial end
2026-09-30
Status
Recruiting
Phase
Early phase I
Treatment
30%Oxygen
60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation
Arms:
Experimental: 30% Oxygen
60%Oxygen
100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation
Arms:
Experimental: 60% Oxygen
Size
100
Primary endpoint
the occurrence of atelectasis
On the operating room within 40 minutes after awakening
Eligibility criteria
Inclusion Criteria: * American Association of Anesthesiologists (ASA) patients with I-II physical condition; * Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position. Exclusion Criteria: * there is a history of acute lung injury with acute respiratory distress syndrome within three months; * Heart failure (classified by new york Heart Association) is greater than grade IV, * there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate \< 30 ml/min); * Body mass index \> 30kg/m2; * coagulation dysfunction; * Operation time exceeds 10h * The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-02-09

1 organization

2 products

2 indications

Product
30%Oxygen
Indication
Atelectasis
Indication
Postoperative
Product
60%Oxygen