HypoxiaNCT01700088
The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy
An observational study of Hypoxia and Post Pulmonary Resection, run by Mahidol University at 1 site in Thailand.
Trial summary
At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via face mask in patient having lung resection surgery. After then if the patient is fine, we'll replace the face mask with nasal cannular untie the next morning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Post Pulmonary Resection
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing lung resection surgery.
Who may be able to join
- age >/= 18 years old
- Patient undergoing lobectomy or pneumonectomy or wedge resection
- ASA 1-3
- Preoperative oxygen saturation < 95 %
Who cannot join
- Cannot communication
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient
At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via face mask in patient having lung resection surgery. After then if the patient is fine, we'll replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen mask can be replace by nasal cannular without any hypoxia.
- Conditions
- Hypoxia, Post Pulmonary Resection
- Keywords
- hypoxemia, Post Pulmonary Resection
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen cannular | After lung resection surgery,every patient will received supplementary oxygen 5 L/minutes via oxygen cannular for 120 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
We continuously monitor oxygen saturation and record every 5 minutes for 30 minutes postoperative.
Measured: 30 minutes
Secondary outcomes (1)
Incidence of hypoxemia
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700088
- Sponsor's protocol ID
- 541/2555(EC2)
- Status last verified
- Dec 2015
- First submitted
- 2 Oct 2012
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient
- ClinicalTrials.gov ID
- NCT01700088
- Acronym / sponsor ID
- 541/2555(EC2)
- Conditions
- Hypoxia, Post Pulmonary Resection
- Keywords
- hypoxemia, Post Pulmonary Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Oct 2012 (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.
At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via face mask in patient having lung resection surgery. After then if the patient is fine, we'll replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen mask can be replace by nasal cannular without any hypoxia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxygen cannular | – | –After lung resection surgery,every patient will received supplementary oxygen 5 L/minutes via oxygen cannular for 120 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing lung resection surgery.
Key inclusion criteria (4 listed)
- age >/= 18 years old
- Patient undergoing lobectomy or pneumonectomy or wedge resection
- ASA 1-3
- Preoperative oxygen saturation < 95 %
Key exclusion criteria (1 listed)
- Cannot communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygen saturation
Time frame: 30 minutes
We continuously monitor oxygen saturation and record every 5 minutes for 30 minutes postoperative.
1 secondary outcome
Incidence of hypoxemia
Time frame: 3 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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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.
Sirilak Suksompong, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Post Pulmonary Resection, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2015. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: 30 minutes). 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 11 Dec 2015.