Evaluation of the Gastric Tube Guide to Place Orogastric Tubes

NCT ID: NCT02925052

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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Conditions

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Orogastric Tube Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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GTG

Gastric tube placement using the Gastric Tube Guide

Group Type EXPERIMENTAL

Gastric Tube Guide

Intervention Type DEVICE

Conventional

Gastric tube placement using a conventional method, according to local protocol.

Group Type OTHER

Conventional placement

Intervention Type DEVICE

Interventions

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Gastric Tube Guide

Intervention Type DEVICE

Conventional placement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Tim piepho

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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GTG-1

Identifier Type: -

Identifier Source: org_study_id

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