Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01783366
Other study ID # PNU03-2013-002
Secondary ID PNUYH03-2013-002
Status Recruiting
Phase N/A
First received January 24, 2013
Last updated February 3, 2013
Start date January 2013
Est. completion date February 2014

Study information

Verified date February 2013
Source Pusan National University Hospital
Contact HYEON-JEONG LEE, PhD
Phone 82-10-76807689
Email lhjksk@pusan.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

we first examined whether use of tube exchange catheter during NGT insertion could increase the success rate on the first attempt of NGT insertion compared with conventional technique. We then addressed the question of whether the use of tube exchange catheter might decrease the possible occurrence of complication associated with YOON insertion.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled

Exclusion Criteria:

- Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
TUBE EXCHANGER


Locations

Country Name City State
Korea, Republic of Pnuyh Anesthesia Yangsan

Sponsors (2)

Lead Sponsor Collaborator
Pusan National University Hospital Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of attempt of NGT insertion After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion through the nostrils until 70cm of NGT was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. Total number of attempts until successful NGT insertion was recorded and tried at least three times, and was considered to have failed.
Thus, procedure time would be the dependent factor of primary endpoin which could increse the success rate of NGT.
after successful insertion of NGT, within 1 hr Yes
Primary Procedure time of NGT insertion After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. NGT insertion time recorded when the NGT begun to insert gently through the nostrils until 70cm of NGT. after successful insertion of NGT, within 1 hr Yes
Secondary presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view The investigators examined the occurrence of complication associated with NGT insertion. After successful NGT insertion, we recorded presence of bleeding of the larynx, and knotting or kinking of NGT using laryngoscopy. after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours Yes