Comparison of Three Methods for NG Tube Placement (NG)

Comparison of Three Methods for NG Tube Placement in Intubated Patients in the Emergency Department During 2016-2018

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.

Study Overview

• Status: Completed
• Conditions: Unconsciousness
• Intervention / Treatment: Procedure: NG tube insertion method

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 8138938728
    • Al-Zahra University Hospital
  • Isfahan, Iran, Islamic Republic of, 8194856781
    • Mehdi Nasr Isfahani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional r blinded; the participants were allocated to have NG tube inserted in a conventional or blind method.	Procedure: NG tube insertion method; a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier; Other Names: NG tube placement technique
Active Comparator: Brake cable; the participants were assigned to have NG tube inserted by use of a bike brake cable as a guide wire.	Procedure: NG tube insertion method; a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier; Other Names: NG tube placement technique
Active Comparator: High way man's hitch; they were selected to have NG tube inserted by use of silk thread knot.	Procedure: NG tube insertion method; a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier; Other Names: NG tube placement technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	success rate was defined as successfully inserted NG tube inside the stomach	Intraoperative (time from entry of the NG tube through nostril til entering inside the stomach or whenever the operator declared.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure duration	it was measured as the total time from start of the procedure til the entry of the tube inside the stomach.	Intraoperative (from nostril entry til sromach entry or operatoe declaration as the end of procedure)

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2017
• Primary Completion (Actual): April 15, 2017
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness
• Other Study ID Numbers: 396780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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.: No