Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography

June 17, 2019 updated by: Memorial Sloan Kettering Cancer Center
This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider.

Description

Inclusion Criteria:

  • The adult population, ages 18 and greater
  • Patients undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider

Exclusion Criteria:

  • Pediatric population (<18 years)
  • Gastric tube inserted under direct visualizing (the use of a Mac or Miller laryngoscope or any video laryngoscope)
  • Inability to visualize gastric tube by ultrasound due to body habitus, analogous anatomy, etc
  • Pre-anesthesia insitu gastric tube
  • Gastric tube inserted by practitioner other than a member of the anesthesia team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with an endotracheal tube
Participants undergoing general anesthesia with an endotracheal tube will have a gastric tube blindly inserted by an anesthesia provider.
Other: Blind Gastric Tube Placement
The provider will be blinded to the ultrasound imaging throughout the entire insertion. This blind insertion process is the standard of care currently practiced at MSKCC. After the provider verbalizes that they have completed the insertion the investigators will stop the ultrasound imaging and complete the data form. No information will be given to the provider about the location of the gastric tube as to not deviate from the standard of care. The only time that information will be provided to the practitioner inserting the tube will be if the tube is positioned in any of the following positions that are thought to be potentially injurious if unrecognized. These positions include intrapulmonary, cranial, nasal or oral pharyngeal placements and diverticular or hiatal hernia sac coiling and remain unrecognized by the practitioner. These are considered positions that have the potential for injury and therefore will be divulged to prevent ensuing injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of malposition of blindly placed gastric tubes by anesthesia providers
Time Frame: Day of procedure
Day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Luis E Tollinche, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Actual)

June 17, 2019

Study Completion (Actual)

June 17, 2019

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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