NCT03430908

Brief Summary

This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

December 22, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

February 7, 2018

Last Update Submit

June 17, 2019

Conditions

Keywords

endotracheal tubegastric tube17-653Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Incidence of malposition of blindly placed gastric tubes by anesthesia providers

    Day of procedure

Study Arms (1)

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

Interventions

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.

Participants with an endotracheal tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

Study Officials

  • Luis E Tollinche, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

December 22, 2017

Primary Completion

June 17, 2019

Study Completion

June 17, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations