Effect of Oxygen During Percutaneous Coronary Interventio... | NCT01413841

Studies
Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief

NCT01413841

Sponsor

Region Skane

Status

Completed

Last Update Posted

Aug 10, 2012Estimated

Enrollment

300Actual

Phase

Phase 2

Conditions

Angina

Interventions

Nasal oxygen
Regular nasal air

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Aug 9, 2011

First Posted Date

Aug 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2012

Last Update Posted Date

Aug 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nasal oxygen	Drug	3 l oxygen	Nasal oxygen
Regular nasal air

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chest pain measured with VAS	After PCI patient is asked in a double blinded about maximum chest during PCI.	1 h

Secondary Outcomes

Measure	Description	Time Frame
Troponin-levels after PCI	Peak troponin the first days after PCI	2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable angina or NST-ACS undergoing PCI

Exclusion Criteria:

Blood oxygen <95%
Cognitive dysfunction
STEMI
Intubation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skane University Hospital, Lund		Lund		22185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23957447	Derived	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases