The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The change of oxygenation index
Study Overview
Brief Summary
The study hypothesized that a relative low oxygen concentration (40%) supplemental would be advantageous to protect the pulmonary function of patients, comparied with conventional high oxygen concentration (80%). Therefore we raise this prospective randomized controlled research.
Detailed Description
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be randomizedly assigned to low oxygen concentration (40%) supplemental or high oxygen concentration(80%) supplemental group. Intra-operative and post-operative pressure of Oxygen in Arterial Blood will be examined, and the surgical outcome will be recorded in the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy.
- •Patients underwent minimally invasive esophagectomy(Thoracolaparoscopic McKeown procedure).
Exclusion Criteria
- •Patients with previous thoracic surgery history.
- •Patients with severe Co-morbidity.
- •Pulmonary function is abnormal in the examination before surgery.
Arms & Interventions
low supplemental oxygen concentration
The group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy.
Intervention: low supplemental oxygen concentration (Procedure)
high supplemental oxygen concentration (conventional)
The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy.
Intervention: high supplemental oxygen concentration (conventional) (Procedure)
Outcomes
Primary Outcomes
The change of oxygenation index
Time Frame: Change from Baseline at post-operative Day1
The change of oxygenation index is an important index to indicate the pulmonary function of patients.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tan, Lijie
Professor of Surgery; Vice Chief, Division of Thoracic Surgery
Fudan University