Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation

April 6, 2018 updated by: University of Malaya

Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation in Anesthetised Intubated Patients: A Prospective Randomized Controlled Trial

This study compares two modified techniques(contralateral cricothyroid pressure and ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and intubated patients with the conventional technique.

Study Overview

Detailed Description

The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious patients may be difficult, with a reported failure rate of nearly 50% on the first attempt, with the head in neutral position there are many different maneuvers to facilitate the insertion of nasogastric tube published.

Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for nasogastric tube insertion will be able to avoid the difficulty.

Therefore we are going to compare this technique with the conventional technique (head in neutral position) with lateral head turning group and contralateral cricothyroid pressure group We hope that the contralateral cricothyroid pressure will increase the success rate, as this will be helpful in intubated patients with neck pathology.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient who is scheduled for elective surgery under general anaesthesia requiring NGT insertion
  • aged 20 to 70 years old
  • with normal airway (Commack Lehane 1 or 2) and neck movements.

Exclusion Criteria:

  • Patient who has nasal stenosis, nasal septal deviation, upper airway deformity, base of skull fracture, oesophageal disorders, coagulopathy, and pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional technique
Nasogastric tube
Nasogastric tube insertion with patient's head in neutral position
Experimental: Contralateral cricothyroid pressure
Nasogastric tube
Cricothyroid pressure is applied externally in the contralateral direction of selected nostril before nasogastric insertion.
Experimental: Ipsilateral head turning
Nasogastric tube
Patient's head is turned to the ipsilateral side of the selected nostril before nasogastric tube insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall success rate
Time Frame: At induction of general anesthesia
Percentage
At induction of general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First attempt success rate
Time Frame: At induction of general anesthesia
Percentage
At induction of general anesthesia
Time taken to successful nasogastric tube placement
Time Frame: At induction of general anesthesia
Procedure start time is defined as the time when the nasogastric tube is inserted through the nostril. The procedure end time is defined as the time of successful insertion and confirmed NGT placement or the time after two failed attempts. The outcome is measured in second.
At induction of general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sook Hui Chaw, M.Med, University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 201510-1718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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