Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Pusan National University Hospital
Sponsor:
Collaborator:
Pusan National University Yangsan Hospital
Information provided by (Responsible Party):
Hyeon-Jeong Lee, Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT01783366
First received: January 24, 2013
Last updated: February 3, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Elective Surgery of Gastrointestinal Tract
100 Adults Aged Between 20 and 70 Years Old
ASA Physical Status of I or II
Device: TUBE EXCHANGER

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients

Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • Number of attempt of NGT insertion [ Time Frame: after successful insertion of NGT, within 1 hr ] [ Designated as safety issue: Yes ]

    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.


  • Procedure time of NGT insertion [ Time Frame: after successful insertion of NGT, within 1 hr ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view [ Time Frame: after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CONTROL
In the control group (Group A) inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position.
Active Comparator: tube-exchanger
The tube-exchanger group (Group B) made use of tube-exchanger G36402 (CAEC, [cook medical, Bloomington, IN]) as a stylet that was lubricated and inserted within 20-F NGT until the tip of the tube-exchanger was at the tip of the NGT
Device: TUBE EXCHANGER
Other Name: TUBE EXCHANGER USAGE

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783366

Contacts
Contact: HYEON-JEONG LEE, PhD 82-10-76807689 lhjksk@pusan.ac.kr

Locations
Korea, Republic of
Pnuyh Anesthesia Recruiting
Yangsan, Korea, Republic of
Sub-Investigator: JI WOOK YOON, PhD         
Sponsors and Collaborators
Pusan National University Hospital
Pusan National University Yangsan Hospital
  More Information

No publications provided

Responsible Party: Hyeon-Jeong Lee, ASSISTANT PROFESSOR, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01783366     History of Changes
Other Study ID Numbers: PNU03-2013-002, PNUYH03-2013-002
Study First Received: January 24, 2013
Last Updated: February 3, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pusan National University Hospital:
nasogastric tube, tube exchange catheter

ClinicalTrials.gov processed this record on September 15, 2014