Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
Primary Purpose
Heart Disease
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Placement of nasogastric tube
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease focused on measuring Nasogastric Tubes, Nausea, Vomiting, Cardiac surgery
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.
Sites / Locations
- Toronto General Hospital, University Health Network
Outcomes
Primary Outcome Measures
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 Outcome Measures
Full Information
NCT ID
NCT00193999
First Posted
September 15, 2005
Last Updated
October 26, 2009
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00193999
Brief Title
Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
Official Title
Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting. A Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Nasogastric Tubes, Nausea, Vomiting, Cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Placement of nasogastric tube
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Djaiani, MD
Organizational Affiliation
Toronto General Hospital, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22290354
Citation
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.
Results Reference
derived
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Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
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