CClinicalTrials.gg
CompletedNCT03430908Updated Jun 18, 2019

Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography

An observational study in Anesthesia, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
166
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia

Keywords

  • endotracheal tube
  • gastric tube
  • 17-653
  • Memorial Sloan Kettering Cancer Center
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
166 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherBlind 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.

05

What researchers measure

Primary outcomes

  1. Incidence of malposition of blindly placed gastric tubes by anesthesia providers

    Time frame: Day of procedure

06

Study locations

1 site
  • Memorial Sloan - Kettering Cancer Center
    New York, New York 10021, United States
07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03430908
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Feb 13, 2018
Start date
Dec 22, 2017
Primary completion
Jun 17, 2019
Completion
Jun 17, 2019
Last update
Jun 18, 2019

Study contacts

Luis E Tollinche, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion