AnginaPhase 2OXYPAINNCT01413841
Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief
A Phase 2 study testing Nasal oxygen and Regular nasal air in people with Angina, run by Region Skane at 1 site in Sweden.
Trial summary
Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina
- What is being tested?
- Nasal oxygen and Regular nasal air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2011to Jun 2012
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable angina or NST-ACS undergoing PCI
Who cannot join
- Blood oxygen <95%
- Cognitive dysfunction
- STEMI
- Intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.
- Conditions
- Angina
- Being tested
- Nasal oxygen, Regular nasal air
- Keywords
- PCI, oxygen
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal oxygenDrug
3 l oxygen
Regular nasal airDrug
3 l nasal air
| Study group | Role | What they receive |
|---|---|---|
| Nasal oxygen | Active comparator | 3 liter per minute Receives: Drug: Nasal oxygen |
| Nasal Air | Placebo comparator | 3 l regular nasal air Receives: Drug: Regular nasal air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest pain measured with VAS
After PCI patient is asked in a double blinded about maximum chest during PCI.
Measured: 1 h
Secondary outcomes (1)
Troponin-levels after PCI
Peak troponin the first days after PCI
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413841
- Sponsor's protocol ID
- DELUCA2
- Acronym
- OXYPAIN
- Status last verified
- Aug 2012
- First submitted
- 9 Aug 2011
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zughaft D, Bhiladvala P, Van Dijkman A, Harnek J, Madsen Hardig B, Bjork J, Ekelund U, Erlinge D. The analgesic effect of oxygen during percutaneous coronary intervention (the OXYPAIN Trial). Acute Card Care. 2013 Sep;15(3):63-8. doi: 10.3109/17482941.2013.822083.
PubMed 23957447
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT01413841
- Acronym / sponsor ID
- OXYPAIN / DELUCA2
- Conditions
- Angina
- Keywords
- PCI, oxygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Aug 2011 (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.
Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal oxygen | Active comparator | Drug: Nasal oxygen3 liter per minute |
| Nasal Air | Placebo comparator | Drug: Regular nasal air3 l regular nasal air |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stable angina or NST-ACS undergoing PCI
Key exclusion criteria (4 listed)
- Blood oxygen <95%
- Cognitive dysfunction
- STEMI
- Intubation
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 |
|---|---|---|
| Nasal oxygen3 l oxygen | Drug | Nasal oxygen |
| Regular nasal air3 l nasal air | Drug | Nasal Air |
Primary outcome
Chest pain measured with VAS
Time frame: 1 h
After PCI patient is asked in a double blinded about maximum chest during PCI.
1 secondary outcome
Troponin-levels after PCI
Time frame: 2 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 10 Aug 2012.
- Derived from this study: PubMed 23957447Zughaft D, Bhiladvala P, Van Dijkman A, Harnek J, Madsen Hardig B, Bjork J, Ekelund U, Erlinge D. The analgesic effect of oxygen during percutaneous coronary intervention (the OXYPAIN Trial). Acute Card Care. 2013 Sep;15(3):63-8. doi: 10.3109/17482941.2013.822083.
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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 2 study testing Nasal oxygen and Regular nasal air in people with Angina, run by Region Skane at 1 site in Sweden.
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 4 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 10 Aug 2012. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Chest pain measured with VAS (time frame: 1 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413841, which also lists 1 linked publication.
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 10 Aug 2012.