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OpenTrials
Completed

NCT Number: NCT02925052

Evaluation of the Gastric Tube Guide to Place Orogastric Tubes

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

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Key information

Conditions

Orogastric Tube Placement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric Tube Guide

Device

Conventional placement

Device

Primary outcomes

  1. Success

    Time frame: 180 seconds

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

Secondary outcomes

  1. Attempts

    Time frame: 180 seconds

    Number of attempts that were necessary to place a gastric tube within 180 seconds

  2. Time

    Time frame: 180 seconds

    Total time needed for gastric tube placement in seconds

  3. Complications

    Time frame: 180 seconds

    Complications such as Bleeding, tooth damage, malposition (Scale yes or no)

  4. Postoperative comfort

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Evaluation of the Gastric Tube Guide to Place Orogastric Tubes: : A Prospective, Randomized Trial

Acronym: GTG

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.