Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography
1 other identifier
observational
166
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
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
December 22, 2017
CompletedFirst Submitted
Initial submission to the registry
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2019
CompletedJune 18, 2019
June 1, 2019
1.5 years
February 7, 2018
June 17, 2019
Conditions
Keywords
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.
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.
Eligibility Criteria
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
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Luis E Tollinche, MD
Memorial Sloan Kettering Cancer Center
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