Nasopharyngeal Airway Guide Nasogastric Tube Placement

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

First attempt successful rate[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Second attempt successful rate[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Overall successful rate insertion[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Time cost during NG tube placement[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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
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
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
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
Mean blood pressure change after NG tube placement[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance
Heart rate change after NG tube placement[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance

Descriptive Information

Brief Title ^ICMJE

Nasopharyngeal Airway Guide Nasogastric Tube Placement

Official Title ^ICMJE

Nasopharyngeal Airway Guide Nasogastric Tube Placement in Anesthetized and Intubated Patient: A Prospective Randomized Control Study

Brief Summary

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. We assume nasopharyngeal airway can facilitate NG tube insertion by opening a channel from nostril to epiglottis and reduce complications by protecting nasal cavity while insertion.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: With nasopharyngeal airway
Nasopharyngeal airway is previously inserted into selected nostril. NG tube is properly lubricated and placed through Nasopharyngeal airway.
Procedure: Without nasopharyngeal airway
NG tube is properly lubricated and placed into selected nostril

Study Arms

Experimental: NG tube placement with nasopharyngeal tube
Active Comparator: NG tube placement with without nasopharyngeal tube

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Taiwan

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Chang Gung Memorial Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

April 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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