Evaluation of the Gastric Tube Guide to Place Orogastric Tubes

Not Applicable

Completed

• Conditions: Orogastric Tube Placement
• Interventions: Device: Gastric Tube Guide; Device: Conventional placement

• Registration Number: NCT02925052
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

A randomized controlled prospective study of orogastric tube placement with the Gastric Tube Guide vs conventional placement.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-01
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Status Verified: 2018-03
• Primary Completion: 2018-06
• Study Completion: 2018-07
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Age ≥ 18 Years
• No concurrent participation in another study
• Capacity to consent
• Present written informed consent of the research participant
• Elective surgery in general anesthesia
• Required orogastric intubation

Exclusion Criteria

• Existing pregnancy
• Emergency patients
• Preexisting pathological findings in the mouth, pharynx or esophagus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GTG	Gastric Tube Guide	Gastric tube placement using the Gastric Tube Guide
Conventional	Conventional placement	Gastric tube placement using a conventional method, according to local protocol.

Primary Outcome Measures

Name	Time	Method
Success	180 seconds	Overall Success after 180 seconds. Yes if a gastric tube was placed in time, no if not

Secondary Outcome Measures

Name	Time	Method
Attempts	180 seconds	Number of attempts that were necessary to place a gastric tube within 180 seconds
Time	180 seconds	Total time needed for gastric tube placement in seconds
Complications	180 seconds	Complications such as Bleeding, tooth damage, malposition (Scale yes or no)
Postoperative comfort	24 hours	Postoperative comfort is assessed using the postoperative section of the "core data set anaesthesia" from the German Society of Anaesthesiology and Intensive Care Medicine

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Mainz, Rhineland-Palatinate, Germany