The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy
The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 3, 2014
December 1, 2013
9 months
October 31, 2013
December 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
low supplemental oxygen concentration
EXPERIMENTALThe group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy.
high supplemental oxygen concentration (conventional)
ACTIVE COMPARATORThe group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy.
Interventions
low supplemental oxygen concentration would be used during the surgery
high supplemental oxygen concentration would be used during the surgery
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Patients with previous thoracic surgery history.
- Patients with severe Co-morbidity.
- Pulmonary function is abnormal in the examination before surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tan, Lijielead
Study Sites (1)
Division of Thoracic Surgery & Anesthesiology, Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lijie Tan, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Surgery; Vice Chief, Division of Thoracic Surgery
Study Record Dates
First Submitted
October 31, 2013
First Posted
January 3, 2014
Study Start
September 1, 2013
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
January 3, 2014
Record last verified: 2013-12