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NCT03430908 Clinical Trial

Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography

Anesthesia Clinical Trial

Official title:
Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03430908
Other study ID # 17-653
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 22, 2017
Est. completion date June 17, 2019

Study information
Verified date June 2019
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date June 17, 2019
Est. primary completion date June 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Memorial Sloan - Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of malposition of blindly placed gastric tubes by anesthesia providers Day of procedure
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