Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedOctober 27, 2009
September 1, 2008
4.2 years
September 15, 2005
October 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- undergoing coronary artery bypass graft and/or valvular surgery,
- age 18-80 year olds
- signed informed consent
- elective or urgent surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
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.
PMID: 22290354DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Djaiani, MD
Toronto General Hospital, University Health Network
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 19, 2005
Study Start
February 1, 2003
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
October 27, 2009
Record last verified: 2008-09