HypoxemiaNCT01917526
The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
A study testing oxygen mask and oxygen cannula in people with Hypoxemia, run by Mahidol University at 1 site in Thailand.
Trial summary
After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary. This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- oxygen mask and oxygen cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General anesthesia
- Age 18-70 years
- American Society of Anesthesiology (ASA)physical status 1-3
- Elective case
Who cannot join
- ASA physical status class 4 or more
- Unstable pulmonary diseases
- BMI > 35 kg/m2
- oxygen saturation < 94% when breathing in room air
- Respiratory muscle weakness eg.myasthenia gravis
- Central nervous system abnormalities eg.drowsiness, hypoventilation
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- Patients who have been intubated or needed ventilatory support before operation
- Plan to remain intubated after the operation
- Intracranial, intrathoracic and upper abdomen surgery
- Patients who nasogastric tube is inserted
- Airway problems eg. sinusitis
- Nasal cavity related surgery or nasal packing eg. endoscopic sinus surgery
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia.
After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary.
This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient.
Read the detailed description
The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices.
- Conditions
- Hypoxemia
- Being tested
- oxygen mask, oxygen cannula
- Keywords
- Oxygen, PACU, Hypoxemia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen maskDevice
Also called Oxygen mask or simple mask
oxygen cannulaDevice
| Study group | Role | What they receive |
|---|---|---|
| oxygen mask | Active comparator | Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded. Receives: Device: oxygen mask |
| Oxygen cannula | Active comparator | Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded. Receives: Device: oxygen cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hypoxemia in Both Groups
Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups
Measured: In PACU (1 hr after anesthesia)
Secondary outcomes (1)
The Causes of Hypoxemia
Causes of hypoxemia in each participant in PACU will be recorded
Measured: In PACU (1 hr after anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoxemiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manee Raksakietisak, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917526
- Sponsor's protocol ID
- 066/2556 (EC3)
- Status last verified
- Nov 2016
- First submitted
- 5 Aug 2013
- Last updated
- 4 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia.
- ClinicalTrials.gov ID
- NCT01917526
- Acronym / sponsor ID
- 066/2556 (EC3)
- Conditions
- Hypoxemia
- Keywords
- Oxygen, PACU, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary.
This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient.
Detailed description
The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen mask | Active comparator | Device: oxygen maskOxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded. |
| Oxygen cannula | Active comparator | Device: oxygen cannulaOxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- General anesthesia
- Age 18-70 years
- American Society of Anesthesiology (ASA)physical status 1-3
- Elective case
Key exclusion criteria (13 listed)
- ASA physical status class 4 or more
- Unstable pulmonary diseases
- BMI > 35 kg/m2
- oxygen saturation < 94% when breathing in room air
- Respiratory muscle weakness eg.myasthenia gravis
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 maskAlso: Oxygen mask or simple mask | Device | oxygen mask |
| oxygen cannula | Device | Oxygen cannula |
Primary outcome
Number of Participants With Hypoxemia in Both Groups
Time frame: In PACU (1 hr after anesthesia)
Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups
1 secondary outcome
The Causes of Hypoxemia
Time frame: In PACU (1 hr after anesthesia)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Manee Raksakietisak, 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 study testing oxygen mask and oxygen cannula in people with Hypoxemia, 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 13 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 4 Jan 2017. 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?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Hypoxemia in Both Groups (time frame: In PACU (1 hr after anesthesia)). 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 4 Jan 2017.