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

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ClinicalTrials.gov Identifier: NCT01413841
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Angina Drug: Nasal oxygen Drug: Regular nasal air Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
Study Start Date : July 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Chest pain measured with VAS [ Time Frame: 1 h ]
    After PCI patient is asked in a double blinded about maximum chest during PCI.


Secondary Outcome Measures :
  1. Troponin-levels after PCI [ Time Frame: 2 days ]
    Peak troponin the first days after PCI


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413841


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01413841     History of Changes
Other Study ID Numbers: DELUCA2
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Region Skane:
PCI
oxygen