Comparison of Three Methods for NG Tube Placement (NG)

• ClinicalTrials.gov Identifier: NCT03699306
• Recruitment Status: Completed
• First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Sponsor: Isfahan University of Medical Sciences
• Information provided by (Responsible Party): Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

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.

Condition or disease	Intervention/treatment	Phase
Unconsciousness	Procedure: NG tube insertion method	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Three Methods for NG Tube Placement in Intubated Patients in the Emergency Department During 2016-2018
• Actual Study Start Date: January 21, 2017
• Actual Primary Completion Date: April 15, 2017
• Actual Study Completion Date: August 10, 2018

Arms and Interventions

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 Name: 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 Name: 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 Name: NG tube placement technique

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Iran, Islamic Republic of

Al-Zahra University Hospital

Isfahan, Iran, Islamic Republic of, 8138938728

Mehdi Nasr Isfahani

Isfahan, Iran, Islamic Republic of, 8194856781

Sponsors and Collaborators

Isfahan University of Medical Sciences

More Information

• Responsible Party: Mehdi Nasr Isfahani, Principle investigator, Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03699306
• Other Study ID Numbers: 396780
• First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases