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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03699306
Other study ID # 396780
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2017
Est. completion date August 10, 2018

Study information

Verified date October 2018
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date August 10, 2018
Est. primary completion date April 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Iran, Islamic Republic of Al-Zahra University Hospital Isfahan
Iran, Islamic Republic of Mehdi Nasr Isfahani Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
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