HypoxiaPhase 1NCT01157624
Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic
A Phase 1 study testing oxygen in people with Hypoxia and Hypercapnia, run by University of Malaya at 1 site in Malaysia.
Trial summary
The investigators hypothesize that this new nasal cannula will prevent lack of oxygen as well as reduce rebreathing of carbon dioxide under ophthalmic drapes during eye surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypercapnia
- What is being tested?
- oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2010to Dec 2010
- Phase
- Phase 1
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (ASA) physical status I, II or III, adult age 40-80 years old group, scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.
Who cannot join
- pre-existing pulmonary diseases, Psychological disorders, Neurological disorders and patients required sedation.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Center
Kuala Lumpur, Federal Teritory, 59100
About this study
The investigators hypothesize that this new nasal cannula will prevent lack of oxygen as well as reduce rebreathing of carbon dioxide under ophthalmic drapes during eye surgery.
Read the detailed description
Surgery involvement the eye has widely been done under local anaesthesia provided by the ophthalmologists. Patients are often awake or mildly sedated during the surgery. However, due to the surgical drape which covers the patients face and beyond in order to maintain sterility of the surgical field, it may lead to hypoxia in these patients and retention of exhaled air within the confined space under the drape. This may lead to patient discomfort and the surgeon will face difficulty when the patient becomes restless and unable to be still for the surgery.
Various studies had been conducted using nasal cannula with oxygen or air which is administered to patients having cataract surgery under local anaesthetics and the results has so far been inconclusive.
One study evaluated the saturation of O2 in arterial blood, the partial pressure of O2 in arterial blood (PaO2), the partial pressure of CO2 in arterial blood (PaCO2) and the pH. The operative blood gas parameters were maintained in the air inhalation patients. Oxygen supplement caused significant increase in the saturation of O2 in arterial blood and in PaO2. There was no difference between the two groups in PaCO2. The pH of the arterial blood showed a statistically significant decrease in the patients with O2 supplement. This shift to more acidotic levels could cause central nervous system depression with reduced respiratory stimulus. Recommendation was to administer air rather than O2 to patients during cataract surgery.[1]
Another clinical trials have shown that O2 application by nasal cannula prevents hypoxia but not rebreathing of CO2 in patients undergoing eye surgery under local anaesthetics.[4]
In this clinical trial, we use Duo flow O2 + CO2 sampling cannula designed in a way to deliver O2 and sampling of expired CO2 gases from both nostril simultaneously. The aim of this study is to randomly administer O2 or air through a new nasal cannula to patients undergoing eye surgery under local anaesthetic and to evaluate the significance of O2 supplement and whether CO2 retention has an indirect effect to it.
- Conditions
- Hypoxia, Hypercapnia
- Being tested
- oxygen
- Keywords
- hypoxia or hypercarbia during surgery under the drape
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenDrug
Also called resuscitation for hypoxia
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
oxygenDrug
Also called resuscitation for hypoxia
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
| Study group | Role | What they receive |
|---|---|---|
| oxygen | Active comparator | Not described Receives: Drug: oxygen |
| air supplement | Placebo comparator | Not described Receives: Drug: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of desaturation during intraoperative period under the drape
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionDec 2010
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 University of MalayaThe 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157624
- Sponsor's protocol ID
- nasalo2
- Status last verified
- Aug 2011
- First submitted
- 5 Jul 2010
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic
- ClinicalTrials.gov ID
- NCT01157624
- Acronym / sponsor ID
- nasalo2
- Conditions
- Hypoxia, Hypercapnia
- Keywords
- hypoxia or hypercarbia during surgery under the drape
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jul 2010 (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 investigators hypothesize that this new nasal cannula will prevent lack of oxygen as well as reduce rebreathing of carbon dioxide under ophthalmic drapes during eye surgery.
Detailed description
Surgery involvement the eye has widely been done under local anaesthesia provided by the ophthalmologists. Patients are often awake or mildly sedated during the surgery. However, due to the surgical drape which covers the patients face and beyond in order to maintain sterility of the surgical field, it may lead to hypoxia in these patients and retention of exhaled air within the confined space under the drape. This may lead to patient discomfort and the surgeon will face difficulty when the patient becomes restless and unable to be still for the surgery.
Various studies had been conducted using nasal cannula with oxygen or air which is administered to patients having cataract surgery under local anaesthetics and the results has so far been inconclusive.
One study evaluated the saturation of O2 in arterial blood, the partial pressure of O2 in arterial blood (PaO2), the partial pressure of CO2 in arterial blood (PaCO2) and the pH. The operative blood gas parameters were maintained in the air inhalation patients. Oxygen supplement caused significant increase in the saturation of O2 in arterial blood and in PaO2. There was no difference between the two groups in PaCO2. The pH of the arterial blood showed a statistically significant decrease in the patients with O2 supplement. This shift to more acidotic levels could cause central nervous system depression with reduced respiratory stimulus. Recommendation was to administer air rather than O2 to patients during cataract surgery.[1]
Another clinical trials have shown that O2 application by nasal cannula prevents hypoxia but not rebreathing of CO2 in patients undergoing eye surgery under local anaesthetics.[4]
In this clinical trial, we use Duo flow O2 + CO2 sampling cannula designed in a way to deliver O2 and sampling of expired CO2 gases from both nostril simultaneously. The aim of this study is to randomly administer O2 or air through a new nasal cannula to patients undergoing eye surgery under local anaesthetic and to evaluate the significance of O2 supplement and whether CO2 retention has an indirect effect to it.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen | Active comparator | Drug: oxygen |
| air supplement | Placebo comparator | Drug: oxygen |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (ASA) physical status I, II or III, adult age 40-80 years old group, scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.
Key exclusion criteria (1 listed)
- pre-existing pulmonary diseases, Psychological disorders, Neurological disorders and patients required sedation.
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 |
|---|---|---|
| oxygenAlso: resuscitation for hypoxiaSubjects who are found to desaturate during treatment with air will be supplement with oxygen | Drug | oxygen |
| oxygenAlso: resuscitation for hypoxiaSubjects who are found to desaturate during treatment with air will be supplement with oxygen | Drug | air supplement |
Primary outcome
Evidence of desaturation during intraoperative period under the drape
Time frame: Intraoperative period
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 17 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxygen in people with Hypoxia and Hypercapnia, run by University of Malaya at 1 site in Malaysia.
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 1 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 17 Aug 2011. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evidence of desaturation during intraoperative period under the drape (time frame: Intraoperative period). 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 17 Aug 2011.