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Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief (OXYPAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01413841
First received: August 9, 2011
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Angina
 Drug: Nasal oxygen
Drug: Regular nasal air
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Chest pain measured with VAS [ Time Frame: 1 h ] [ Designated as safety issue: No ]
    After PCI patient is asked in a double blinded about maximum chest during PCI.


Secondary Outcome Measures:
  • Troponin-levels after PCI [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Peak troponin the first days after PCI


Enrollment: 300
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nasal oxygen
3 liter per minute
 Drug: Nasal oxygen
3 l oxygen
Placebo Comparator: Nasal Air
3 l regular nasal air
 Drug: Regular nasal air
3 l nasal air

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable angina or NST-ACS undergoing PCI

Exclusion Criteria:

  • Blood oxygen <95%
  • Cognitive dysfunction
  • STEMI
  • Intubation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413841

Locations
Sweden
Skane University Hospital, Lund
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01413841     History of Changes
Other Study ID Numbers: DELUCA2
Study First Received: August 9, 2011
Last Updated: August 9, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
PCI
oxygen

ClinicalTrials.gov processed this record on May 23, 2013