NCT00193999

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 27, 2009

Status Verified

September 1, 2008

Enrollment Period

4.2 years

First QC Date

September 15, 2005

Last Update Submit

October 26, 2009

Conditions

Keywords

Nasogastric TubesNauseaVomitingCardiac surgery

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Heart DiseasesNauseaVomiting

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • George Djaiani, MD

    Toronto General Hospital, University Health Network

    PRINCIPAL INVESTIGATOR

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

Locations