Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients

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.

Study Overview

• Status: Unknown
• Conditions: Elective Surgery of Gastrointestinal Tract; 100 Adults Aged Between 20 and 70 Years Old; ASA Physical Status of I or II
• Intervention / Treatment: Device: TUBE EXCHANGER

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of
    • Recruiting
    • Pnuyh Anesthesia
    • Sub-Investigator: JI WOOK YOON, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: TUBE EXCHANGER USAGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Collaborators: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 3, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: nasogastric tube, tube exchange catheter
• Other Study ID Numbers: PNU03-2013-002; PNUYH03-2013-002 (Other Identifier: PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL)