Lung SurgeryPhase 4NCT01725464
The Effect of Nasal Cannula During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy
A Phase 4 study testing oxygen cannular in people with Lung Surgery and Hypoxia, run by Mahidol University at 1 site in Thailand.
Trial summary
During early postoperative after lung resection surgery, patients without oxygen supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask or cannular. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Surgery, Hypoxia, Postoperative
- What is being tested?
- oxygen cannular
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to Aug 2013
- Phase
- Phase 4
- 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
Who may be able to join
- age =/> 18 years
- lobectomy or pneumonectomy or wedge resection
- ASA 1-3
- preoperative oxygen saturation < 95 %
- receiving epidural analgesia
Who cannot join
- cannot communication
Trial locations and contacts
1 site in 1 country.
About this study
During early postoperative after lung resection surgery, patients without oxygen supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask or cannular. In this study the investigators want to the sudy the effect of oxygen supplementation via oxygen cannular during the first 120 minutes after surgery
- Conditions
- Lung Surgery, Hypoxia, Postoperative
- Being tested
- oxygen cannular
- Keywords
- thoracotomy, oxygen saturation, postoperative
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen cannularDevice
Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative
| Study group | Role | What they receive |
|---|---|---|
| oxygen cannular | Experimental | Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative Receives: Device: oxygen cannular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean oxygen saturation at 30 minutes postoperative
Measured: 30 minutes
Secondary outcomes (1)
incidence of oxygen saturation < 95% between 120 minutes until 3 days postoperative
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT01725464
- Sponsor's protocol ID
- 541/2555(EC)
- Status last verified
- Aug 2013
- First submitted
- 8 Nov 2012
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasal Cannula During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT01725464
- Acronym / sponsor ID
- 541/2555(EC)
- Conditions
- Lung Surgery, Hypoxia, Postoperative
- Keywords
- thoracotomy, oxygen saturation, postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Nov 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.
During early postoperative after lung resection surgery, patients without oxygen supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask or cannular. In this study the investigators want to the sudy the effect of oxygen supplementation via oxygen cannular during the first 120 minutes after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oxygen cannular | Experimental | Device: oxygen cannularPatient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age =/> 18 years
- lobectomy or pneumonectomy or wedge resection
- ASA 1-3
- preoperative oxygen saturation < 95 %
- receiving epidural analgesia
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen cannularPatient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative | Device | oxygen cannular |
Primary outcome
Mean oxygen saturation at 30 minutes postoperative
Time frame: 30 minutes
1 secondary outcome
incidence of oxygen saturation < 95% between 120 minutes until 3 days postoperative
Time frame: 3 days
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 19 Aug 2013.
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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?
A Phase 4 study testing oxygen cannular in people with Lung Surgery and Hypoxia, 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 5 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 19 Aug 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean oxygen saturation at 30 minutes postoperative (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 19 Aug 2013.