NCT03697642

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
Last Updated

February 26, 2020

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

October 4, 2018

Last Update Submit

February 23, 2020

Conditions

Nasogastric TubeNasopharyngeal AirwayAnesthesia, General

Outcome Measures

Primary Outcomes (4)

  • First attempt successful rate

    with or without Nasopharyngeal airway assistance

    can be know after NG tube placement immediately

  • Second attempt successful rate

    with or without Nasopharyngeal airway assistance

    can be know after NG tube placement immediately

  • Overall successful rate insertion

    with or without Nasopharyngeal airway assistance

    can be know after NG tube placement immediately

  • Time cost during NG tube placement

    with or without Nasopharyngeal airway assistance

    can be know after NG tube placement immediately

Secondary Outcomes (6)

  • Incidence of NG tube coiling

    can be know after NG tube placement immediately

  • Incidence of NG tube kinking

    can be know after NG tube placement immediately

  • Incidence of NG tube knotting

    can be know after NG tube placement immediately

  • Incidence of epistaxis after NG tube placement

    can be know after NG tube placement immediately

  • Mean blood pressure change after NG tube placement

    can be know after NG tube placement immediately

  • +1 more secondary outcomes

Study Arms (2)

NG tube placement with nasopharyngeal tube

EXPERIMENTAL
Procedure: With nasopharyngeal airway

NG tube placement without nasopharyngeal tube

ACTIVE COMPARATOR
Procedure: Without nasopharyngeal airway

Interventions

With nasopharyngeal airwayPROCEDURE

Nasopharyngeal airway is previously inserted into selected nostril. NG tube is properly lubricated and placed through Nasopharyngeal airway.

NG tube placement with nasopharyngeal tube
Without nasopharyngeal airwayPROCEDURE

NG tube is properly lubricated and placed into selected nostril

NG tube placement without nasopharyngeal tube

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Location

Related Publications (1)

  • Huang TY, Lin JR, Chung YT. A preinstalled nasopharyngeal airway in the right nasal passageway to facilitate nasogastric intubation in anesthetized and intubated patients: a prospective randomized controlled trial. BMC Gastroenterol. 2020 Nov 3;20(1):365. doi: 10.1186/s12876-020-01514-6.

    PMID: 33143639DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 5, 2018

Study Start

October 24, 2018

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

February 26, 2020

Record last verified: 2019-04

Locations

TW(1)