The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial

Conditions
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Oxygenation Index

Intervention / Treatment
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* Procedure: low supplemental oxygen concentration
* Procedure: high supplemental oxygen concentration (conventional)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low supplemental oxygen concentration<br>The group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy. | Procedure: low supplemental oxygen concentration<br>* low supplemental oxygen concentration would be used during the surgery<br>|
| Active Comparator: high supplemental oxygen concentration (conventional)<br>The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy. | Procedure: high supplemental oxygen concentration (conventional)<br>* high supplemental oxygen concentration would be used during the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of oxygenation index | The change of oxygenation index is an important index to indicate the pulmonary function of patients. | Change from Baseline at post-operative Day1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally invasive esophagectomy; pulmonary function