Safety Study of Inhaling Carbon Monoxide in Healthy Volun... | NCT01050933

Studies
Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers

NCT01050933

Sponsor

Queen's University

Status

Terminated

Last Update Posted

Nov 17, 2015Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Healthy

Interventions

250 ppm carbon monoxide

Countries

Canada

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

resident left and no one to take over

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Jan 15, 2010

First Posted Date

Jan 18, 2010Estimated

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

Nov 15, 2015

Last Update Posted Date

Nov 17, 2015Estimated

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

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

Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.

This preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation.

We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO with minimal side effects. It is also anticipated that for each dose of CO administered, the blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood levels of CO will return to baseline level within 24 hours following the last dose of CO.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbon Monoxide	Experimental	Healthy volunteers will receive 250 ppm of carbon monoxide by face mask. This dose will be administered for 1 hour with continuous COHb monitoring. At baseline and at each half hour time point, a blood sample will be drawn to be analyzed by the gas chromatograph. After 1 hour, the volunteer will be excused and asked to return in 4 hours and this procedure repeated. At any point, if the COHb level reaches 10%, administration of CO will be terminated.	Drug: 250 ppm carbon monoxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
250 ppm carbon monoxide	Drug	250 ppm of inhaled carbon monoxide over one hour	Carbon Monoxide

Measure	Description	Time Frame
Adverse Event Rate		Before and after carbon monoxide exposure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women, age > 18 years.
Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
No prior smoking history.
BMI between 16 and 30 inclusive.
In good health as per medical history, physical exam, vital signs & ECG.

Exclusion Criteria:

Exposure to carbon monoxide during the 48 hours prior to the study day.
Occupational exposure to CO.
Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.
Baseline blood level of COHb >2%.
Patients with underlying lung disease such as asthma or COPD.
Baseline oxygen saturation <92% on room air.
Planned pregnancy, already pregnant or breastfeeding.
Participation in another clinical trial within 2 months prior to study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Belliveau, MD	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kingston General Hospital		Kingston	Ontario		Canada