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NCT01413841 Clinical Trial

Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief

Angina Clinical Trial

— OXYPAIN  

Official title:
Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01413841
Other study ID # DELUCA2
Secondary ID
Status Completed
Phase Phase 2
First received August 9, 2011
Last updated August 9, 2012
Start date July 2011
Est. completion date June 2012

Study information
Verified date August 2012
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Stable angina or NST-ACS undergoing PCI

Exclusion Criteria:

- Blood oxygen <95%

- Cognitive dysfunction

- STEMI

- Intubation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nasal oxygen
3 l oxygen
• Regular nasal air
3 l nasal air

Locations
Country Name City State
Sweden Skane University Hospital, Lund Lund

Sponsors (1)
Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chest pain measured with VAS After PCI patient is asked in a double blinded about maximum chest during PCI. 1 h No
Secondary Troponin-levels after PCI Peak troponin the first days after PCI 2 days No
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