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Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief

NCT ID: NCT01413841

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Angina

Keywords

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PCI oxygen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Nasal oxygen

3 liter per minute

Group Type ACTIVE_COMPARATOR

Nasal oxygen

Intervention Type DRUG

3 l oxygen

Nasal Air

3 l regular nasal air

Group Type PLACEBO_COMPARATOR

Regular nasal air

Intervention Type DRUG

3 l nasal air

Interventions

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Nasal oxygen

3 l oxygen

Intervention Type DRUG

Regular nasal air

3 l nasal air

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stable angina or NST-ACS undergoing PCI

Exclusion Criteria

* Blood oxygen \<95%
* Cognitive dysfunction
* STEMI
* Intubation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Skane University Hospital, Lund

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 23957447 (View on PubMed)

Other Identifiers

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DELUCA2

Identifier Type: -

Identifier Source: org_study_id