- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557204
Comparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated Patients
Comparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated Patients: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Two hundred adult patients, who received general anaesthesia for elective abdominal surgeries that required nasogastric tube insertion, will be randomized by means of a computer-generated randomization order into four groups: Conventional group (Group C), head in the lateral position group (Group L), endotracheal tube assisted group (group ET) and video laryngoscope group (group MG).
Success rate of the selected technique (first attempt, second attempt and overall), duration of insertion for selected technique, complications such as kinking and mucosal bleeding will be noted.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Antalya, Turkey, 07100
- Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who received general anaesthesia for elective abdominal surgeries that required nasogastric tube insertion.
Exclusion Criteria:
- Patients with a history of coagulopathy,
- nasal stenosis,
- upper respiratory tract diseases or anomalies,
- esophageal varix, esophageal hiatus hernia,
- base of skull fracture,
- loose teeth,
- Cormack and Lehane and/or Mallampati scores of 3 or 4,
- patients younger than 18 years and older than 70 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional technique
the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.
|
the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.
|
Experimental: head in the lateral position technique
the patient's head will be turned to the right lateral position.
Nasogastric tube will be inserted through the right nostril without any maneuvers of the neck.
|
the patient's head will be turned to the right lateral position.
Nasogastric tube will be inserted through the right nostril without any maneuvers of the neck.
|
Experimental: endotracheal tube assisted technique
Nasogastric tube will be inserted the trimmed 7.5 mm internal diameter endotracheal tube what cut proximal end with sterile scissors and endotracheal tube will be advanced blindly into the oral cavity to a depth of approximately 18 cm without laryngoscope together the nasogastric tube.
|
Nasogastric tube will be inserted the trimmed 7.5 mm internal diameter endotracheal tube what cut proximal end with sterile scissors and endotracheal tube will be advanced blindly into the oral cavity to a depth of approximately 18 cm without laryngoscope together the nasogastric tube.
|
Experimental: videolaryngoscope technique
Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.
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Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference in the first attempt and overall success rate
Time Frame: participants will be followed to the starting from the NG tube insert through the nostril until the confirm to successful insertion into stomach.
|
investigate the difference in the first attempt and overall success rate (with percentage) of different techniques for insertion of nasogastric tube.
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participants will be followed to the starting from the NG tube insert through the nostril until the confirm to successful insertion into stomach.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference of the duration of insertion and complications during insertion
Time Frame: participants will be followed for the duration of intraoperative period and postoperative 4 hours.
|
investigate the difference of the duration of insertion (in seconds) using the selected technique and complications (with number and percentage) during insertion such as kinking, knotting, mucosal bleeding
|
participants will be followed for the duration of intraoperative period and postoperative 4 hours.
|
Collaborators and Investigators
Investigators
- Study Director: Ali S Kavakli, MD, Antalya Training and Research Hospital
Publications and helpful links
General Publications
- Kirtania J, Ghose T, Garai D, Ray S. Esophageal guidewire-assisted nasogastric tube insertion in anesthetized and intubated patients: a prospective randomized controlled study. Anesth Analg. 2012 Feb;114(2):343-8. doi: 10.1213/ANE.0b013e31823be0a4. Epub 2011 Nov 21.
- Moharari RS, Fallah AH, Khajavi MR, Khashayar P, Lakeh MM, Najafi A. The GlideScope facilitates nasogastric tube insertion: a randomized clinical trial. Anesth Analg. 2010 Jan 1;110(1):115-8. doi: 10.1213/ANE.0b013e3181be0e43. Epub 2009 Oct 27.
- Appukutty J, Shroff PP. Nasogastric tube insertion using different techniques in anesthetized patients: a prospective, randomized study. Anesth Analg. 2009 Sep;109(3):832-5. doi: 10.1213/ane.0b013e3181af5e1f.
- Kwon OS, Cho GC, Jo CH, Cho YS. Endotracheal tube-assisted orogastric tube insertion in intubated patients in an ED. Am J Emerg Med. 2015 Feb;33(2):177-80. doi: 10.1016/j.ajem.2014.11.004. Epub 2014 Nov 13.
- Chun DH, Kim NY, Shin YS, Kim SH. A randomized, clinical trial of frozen versus standard nasogastric tube placement. World J Surg. 2009 Sep;33(9):1789-92. doi: 10.1007/s00268-009-0144-x.
- Bong CL, Macachor JD, Hwang NC. Insertion of the nasogastric tube made easy. Anesthesiology. 2004 Jul;101(1):266. doi: 10.1097/00000542-200407000-00058. No abstract available.
- Ghatak T, Samanta S, Baronia AK. A new technique to insert nasogastric tube in an unconscious intubated patient. N Am J Med Sci. 2013 Jan;5(1):68-70. doi: 10.4103/1947-2714.106215.
- Tsai YF, Luo CF, Illias A, Lin CC, Yu HP. Nasogastric tube insertion in anesthetized and intubated patients: a new and reliable method. BMC Gastroenterol. 2012 Aug 1;12:99. doi: 10.1186/1471-230X-12-99.
- Okabe T, Goto G, Hori Y, Sakamoto A. Gastric tube insertion under direct vision using the King Vision video laryngoscope: a randomized, prospective, clinical trial. BMC Anesthesiol. 2014 Sep 25;14:82. doi: 10.1186/1471-2253-14-82. eCollection 2014.
- Illias AM, Hui YL, Lin CC, Chang CJ, Yu HP. A comparison of nasogastric tube insertion techniques without using other instruments in anesthetized and intubated patients. Ann Saudi Med. 2013 Sep-Oct;33(5):476-81. doi: 10.5144/0256-4947.2013.476.
- Milsom SA, Sweeting JA, Sheahan H, Haemmerle E, Windsor JA. Naso-enteric Tube Placement: A Review of Methods to Confirm Tip Location, Global Applicability and Requirements. World J Surg. 2015 Sep;39(9):2243-52. doi: 10.1007/s00268-015-3077-6.
- Halloran O, Grecu B, Sinha A. Methods and complications of nasoenteral intubation. JPEN J Parenter Enteral Nutr. 2011 Jan;35(1):61-6. doi: 10.1177/0148607110370976. Epub 2010 Oct 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AntalyaTRH 007
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