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OpenTrials
Completed

NCT Number: NCT01413841

Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief

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.

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Key information

Conditions

Angina Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skane University Hospital, Lund

Lund, 22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable angina or NST-ACS undergoing PCI

Exclusion criteria

  • Blood oxygen <95%
  • Cognitive dysfunction
  • STEMI
  • Intubation

Treatment and study plan

Nasal oxygen

Drug

3 l oxygen

Regular nasal air

Drug

3 l nasal air

Primary outcomes

  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 outcomes

  1. Troponin-levels after PCI

    Time frame: 2 days

    Peak troponin the first days after PCI

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Acronym: OXYPAIN

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2011
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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