NCT01413841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

August 9, 2011

Last Update Submit

August 9, 2012

Conditions

Angina

Keywords

PCIoxygen

Outcome Measures

Primary Outcomes (1)

  • Chest pain measured with VAS

    After PCI patient is asked in a double blinded about maximum chest during PCI.

    1 h

Secondary Outcomes (1)

  • Troponin-levels after PCI

    2 days

Study Arms (2)

Nasal oxygen

ACTIVE COMPARATOR

3 liter per minute

Drug: Nasal oxygen

Nasal Air

PLACEBO COMPARATOR

3 l regular nasal air

Drug: Regular nasal air

Interventions

Nasal oxygenDRUG

3 l oxygen

Nasal oxygen
Regular nasal airDRUG

3 l nasal air

Nasal Air

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable angina or NST-ACS undergoing PCI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital, Lund

Lund, 22185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 23957447DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

SE(1)