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Comparison of Three Methods for NG Tube Placement (NG)

Primary Purpose

Unconsciousness

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
NG tube insertion method
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Unconsciousness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all intubated patients, referred to the emergency department

Exclusion Criteria:

  • the presence of symptoms of skull base fracture,
  • bleeding disorders and coagulopathies,
  • maxillofacial trauma, which led to deformity and impairment of NG tube,
  • upper respiratory tract diseases and anomalies,
  • nasal congestion and nostril stenosis,
  • esophageal disorder (esophageal stenosis and esophageal varicose vein),
  • and a history of head and neck radiotherapy.
  • Patients who had been intubated in other centers and being referred to these two centers were also excluded.

Sites / Locations

  • Al-Zahra University Hospital
  • Mehdi Nasr Isfahani

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional r blinded

Brake cable

High way man's hitch

Arm Description

the participants were allocated to have NG tube inserted in a conventional or blind method.

the participants were assigned to have NG tube inserted by use of a bike brake cable as a guide wire.

they were selected to have NG tube inserted by use of silk thread knot.

Outcomes

Primary Outcome Measures

success rate
success rate was defined as successfully inserted NG tube inside the stomach

Secondary Outcome Measures

procedure duration
it was measured as the total time from start of the procedure til the entry of the tube inside the stomach.

Full Information

First Posted
October 1, 2018
Last Updated
October 4, 2018
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03699306
Brief Title
Comparison of Three Methods for NG Tube Placement
Acronym
NG
Official Title
Comparison of Three Methods for NG Tube Placement in Intubated Patients in the Emergency Department During 2016-2018
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background and Aim: Tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. This method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. The purpose of this study was to compare the three methods of the NG tube placement in intubated patients in the emergency department of university-affiliated hospitals of Isfahan from2016 to 2018. Materials and Methods: This study was a randomized and prospective clinical trial. The statistical population of this study was all patients who had been referred to the emergency department of Al-Zahra and Ayatollah Kashani hospitals in Isfahan between2016and2018. The sample size was 25 in each group, and in total 75 subjects. The first group was NG tube insertion by the conventional method, the second group was using brake cable and the third group was embeddedby highwayman's hitch or draw hitch, using a silk thread. For all patients, demographic characteristics and possible complications were recorded. Finally, the data were analyzed using SPSS20 software at two statistical levels of descriptive and inferential.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unconsciousness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional r blinded
Arm Type
Active Comparator
Arm Description
the participants were allocated to have NG tube inserted in a conventional or blind method.
Arm Title
Brake cable
Arm Type
Active Comparator
Arm Description
the participants were assigned to have NG tube inserted by use of a bike brake cable as a guide wire.
Arm Title
High way man's hitch
Arm Type
Active Comparator
Arm Description
they were selected to have NG tube inserted by use of silk thread knot.
Intervention Type
Procedure
Intervention Name(s)
NG tube insertion method
Other Intervention Name(s)
NG tube placement technique
Intervention Description
a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier
Primary Outcome Measure Information:
Title
success rate
Description
success rate was defined as successfully inserted NG tube inside the stomach
Time Frame
Intraoperative (time from entry of the NG tube through nostril til entering inside the stomach or whenever the operator declared.)
Secondary Outcome Measure Information:
Title
procedure duration
Description
it was measured as the total time from start of the procedure til the entry of the tube inside the stomach.
Time Frame
Intraoperative (from nostril entry til sromach entry or operatoe declaration as the end of procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all intubated patients, referred to the emergency department Exclusion Criteria: the presence of symptoms of skull base fracture, bleeding disorders and coagulopathies, maxillofacial trauma, which led to deformity and impairment of NG tube, upper respiratory tract diseases and anomalies, nasal congestion and nostril stenosis, esophageal disorder (esophageal stenosis and esophageal varicose vein), and a history of head and neck radiotherapy. Patients who had been intubated in other centers and being referred to these two centers were also excluded.
Facility Information:
Facility Name
Al-Zahra University Hospital
City
Isfahan
ZIP/Postal Code
8138938728
Country
Iran, Islamic Republic of
Facility Name
Mehdi Nasr Isfahani
City
Isfahan
ZIP/Postal Code
8194856781
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Three Methods for NG Tube Placement

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