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Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Hyeon-Jeong Lee, Pusan National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01783366
First Posted: February 4, 2013
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pusan National University Yangsan Hospital
Information provided by (Responsible Party):
Hyeon-Jeong Lee, Pusan National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients

Further study details as provided by Hyeon-Jeong Lee, Pusan National University Hospital:

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

    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 ]
    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 ]
    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

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL )
First Submitted: January 24, 2013
First Posted: February 4, 2013
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Hyeon-Jeong Lee, Pusan National University Hospital:
nasogastric tube, tube exchange catheter