Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea... | NCT00193999

Studies
Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting

NCT00193999

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Oct 27, 2009Estimated

Enrollment

300Estimated

Phase

Phase 4

Conditions

Heart Disease

Interventions

Placement of nasogastric tube

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

Sep 2008

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

Feb 2003

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 19, 2005Estimated

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

Oct 26, 2009

Last Update Posted Date

Oct 27, 2009Estimated

Description Module

Brief Summary

Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG) tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are routinely used in patients undergoing surgery. They are presumed to reduce postoperative nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric volumes; however, their insertion and use is not however without potentially serious complications. Existing literature does not address their efficacy in reducing PONV after cardiac surgery. However, current evidence suggests that up to 50% of patients in this group suffer significant nausea and vomiting. The objective of this study is to determine whether NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Name	Type	Description	Arm Group Labels	Other Names
Placement of nasogastric tube	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome measures will be the incidence and severity of postoperative nausea and vomiting as well as paint while the patient is in the CVICU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing coronary artery bypass graft and/or valvular surgery,
age 18-80 year olds
signed informed consent
elective or urgent surgery

Exclusion Criteria:

past history of oesophageal surgery, oesophageal varices or stricture,
patients who have received antiemetic medication in the 24 hours before surgery
emergency surgery
patients that require re-sternotomy, or are not extubated 24 hours after admission to the intensive care unit, will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
George Djaiani, MD	Toronto General Hospital, University Health Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto General Hospital, University Health Network		Toronto	Ontario	M5G 2C4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22290354	Derived	Djaiani G, Katznelson R, Fedorko L, Rao V, Green R, Carroll J, Katski J. Early benefit of preserved cognitive function is not sustained at one-year after cardiac surgery: a longitudinal follow-up of the randomized controlled trial. Can J Anaesth. 2012 May;59(5):449-55. doi: 10.1007/s12630-012-9675-y.

ID	Term
D006331	Heart Diseases
D009325	Nausea
D014839	Vomiting

ID	Term
D002318	Cardiovascular Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms