The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy

Oxygenation Index Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02026739
• Other study ID #: ZSHTA2013001
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2013
• Last updated: December 31, 2013
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2013
• Source: Fudan University
• Contact: Hao Wang, MD
• Phone: +86-21-64041990
• Email: wang.hao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy.

2. Patients underwent minimally invasive esophagectomy(Thoracolaparoscopic McKeown procedure).

Exclusion Criteria:

1. Patients with previous thoracic surgery history.

2. Patients with severe Co-morbidity.

3. Pulmonary function is abnormal in the examination before surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxygenation Index

Intervention

Procedure:
• low supplemental oxygen concentration
low supplemental oxygen concentration would be used during the surgery
• high supplemental oxygen concentration (conventional)
high supplemental oxygen concentration would be used during the surgery

Locations

Country	Name	City	State
China	Division of Thoracic Surgery & Anesthesiology, Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tan, Lijie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes