- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697642
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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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