NCT03699306

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 21, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

October 1, 2018

Last Update Submit

October 4, 2018

Conditions

Unconsciousness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • procedure duration

    Intraoperative (from nostril entry til sromach entry or operatoe declaration as the end of procedure)

Study Arms (3)

Conventional r blinded

ACTIVE COMPARATOR

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

Procedure: NG tube insertion method

Brake cable

ACTIVE COMPARATOR

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

High way man's hitch

ACTIVE COMPARATOR

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

Procedure: NG tube insertion method

Interventions

NG tube insertion methodPROCEDURE

a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier

Also known as: NG tube placement technique
Brake cableConventional r blindedHigh way man's hitch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all intubated patients, referred to the emergency department

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Zahra University Hospital

Isfahan, 8138938728, Iran

Location

Mehdi Nasr Isfahani

Isfahan, 8194856781, Iran

Location

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 9, 2018

Study Start

January 21, 2017

Primary Completion

April 15, 2017

Study Completion

August 10, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(2)