Oxygenation IndexNCT02026739
The Optimal Intraoperative Supplemental Oxygen Administration During Minimally Invasive Esophagectomy
A study testing low supplemental oxygen concentration and high supplemental oxygen concentration (conventional) in people with Oxygenation Index, run by Tan, Lijie at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oxygenation Index
- What is being tested?
- low supplemental oxygen concentration and high supplemental oxygen concentration (conventional)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients with previous thoracic surgery history.
- Patients with severe Co-morbidity.
- Pulmonary function is abnormal in the examination before surgery.
Trial locations and contacts
1 site in 1 country.
Hao Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Division of Thoracic Surgery & Anesthesiology, Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Hao Wang, MD, wang.hao@zs-hospital.sh.cn
Fang Fang, MD, fang.fang@zs-hospital.sh.cn
About this study
Official title: The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Oxygenation Index
- Being tested
- low supplemental oxygen concentration, high supplemental oxygen concentration (conventional)
- Keywords
- minimally invasive esophagectomy; pulmonary function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low supplemental oxygen concentrationProcedure or surgery
low supplemental oxygen concentration would be used during the surgery
high supplemental oxygen concentration (conventional)Procedure or surgery
high supplemental oxygen concentration would be used during the surgery
| Study group | Role | What they receive |
|---|---|---|
| low supplemental oxygen concentration | Experimental | The group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy. Receives: Procedure: low supplemental oxygen concentration |
| high supplemental oxygen concentration (conventional) | Active comparator | The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy. Receives: Procedure: high supplemental oxygen concentration (conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of oxygenation index
The change of oxygenation index is an important index to indicate the pulmonary function of patients.
Measured: Change from Baseline at post-operative Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygenation IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan, Lijie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tan, Lijie, Fudan University
- Investigators
- Lijie Tan, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026739
- Sponsor's protocol ID
- ZSHTA2013001
- Status last verified
- Dec 2013
- First submitted
- 31 Oct 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02026739
- Acronym / sponsor ID
- ZSHTA2013001
- Conditions
- Oxygenation Index
- Keywords
- minimally invasive esophagectomy; pulmonary function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tan, LijieUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low supplemental oxygen concentration | Experimental | Procedure: low supplemental oxygen concentrationThe group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy. |
| high supplemental oxygen concentration (conventional) | Active comparator | Procedure: high supplemental oxygen concentration (conventional)The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Patients with previous thoracic surgery history.
- Patients with severe Co-morbidity.
- Pulmonary function is abnormal in the examination before surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low supplemental oxygen concentrationlow supplemental oxygen concentration would be used during the surgery | Procedure or surgery | low supplemental oxygen concentration |
| high supplemental oxygen concentration (conventional)high supplemental oxygen concentration would be used during the surgery | Procedure or surgery | high supplemental oxygen concentration (conventional) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Wang, MD contact
Lijie Tan, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low supplemental oxygen concentration and high supplemental oxygen concentration (conventional) in people with Oxygenation Index, run by Tan, Lijie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Wang, MD (+86-21-64041990 ext. 2914, wang.hao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of oxygenation index (time frame: Change from Baseline at post-operative Day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.