Nasopharyngeal Airway Guide Nasogastric Tube Placement

February 23, 2020 updated by: Chang Gung Memorial Hospital

A Nasopharyngeal Airway Facilitates Nasogastric Intubation in Anesthetized Intubated Patients: A Randomized Controlled Trial

Nasogastric tube placement is essential for various surgery and critically ill patients. However, NG tube insertion in anesthetized, paralyzed, and intubated or unconscious patients may be difficult, with reported success rate less 50% on the first attempt without any auxiliary devices. Endotracheal tube intubation narrow the space of oropharynx and hypopharynx. Loss ability to swallow and tongue drop also made the NG tube coil in the mouth easily. Investigators assume nasopharyngeal airway can facilitate NG tube insertion by opening a channel from nostril to epiglottis and reduce complications by protecting nasal cavity while inserting NG.

Study Overview

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 10507
        • Chang Gung Memorial Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient should be > 20 years old, ASA 1~3 under going schedule general anesthesia with endotracheal tube intubation
  • Patient who required NG tube placement for perioperative care

Exclusion Criteria:

  • Coagulation abnormality (PLT≤100000, INR>1.2 & PT≥13)
  • Hemodynamic unstable (with inotropic agent use)
  • Arrythmia
  • Esophageal varices or stricture, Esophageal cancer, trauma or previous esophageal surgery
  • Gastric cancer involve cardiac orifice
  • Corrosive chemical (strong acid or alkali) ingestion
  • Skull base fracture
  • Recent nasal surgery, nasal fracture or severe nasal obstruction
  • Loose teeth that make endotracheal tube can not fix right side

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NG tube placement with nasopharyngeal tube
Nasopharyngeal airway is previously inserted into selected nostril. NG tube is properly lubricated and placed through Nasopharyngeal airway.
Active Comparator: NG tube placement without nasopharyngeal tube
NG tube is properly lubricated and placed into selected nostril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First attempt successful rate
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance
can be know after NG tube placement immediately
Second attempt successful rate
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance
can be know after NG tube placement immediately
Overall successful rate insertion
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance
can be know after NG tube placement immediately
Time cost during NG tube placement
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance
can be know after NG tube placement immediately

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of NG tube coiling
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance during NG tube insertion
can be know after NG tube placement immediately
Incidence of NG tube kinking
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance during NG tube insertion
can be know after NG tube placement immediately
Incidence of NG tube knotting
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance during NG tube insertion
can be know after NG tube placement immediately
Incidence of epistaxis after NG tube placement
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance during NG tube insertion
can be know after NG tube placement immediately
Mean blood pressure change after NG tube placement
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance
can be know after NG tube placement immediately
Heart rate change after NG tube placement
Time Frame: can be know after NG tube placement immediately
with or without Nasopharyngeal airway assistance
can be know after NG tube placement immediately

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

October 24, 2018

Primary Completion (Actual)

September 3, 2019

Study Completion (Actual)

September 3, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 201800138A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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