Comparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated Patients

Disorder of Abdomen Clinical Trial

Official title:

Comparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated Patients: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557204
• Other study ID #: AntalyaTRH 007
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: December 6, 2015
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of nasogastric tube. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as kinking, knotting, mucosal bleeding

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disorder of Abdomen

Intervention

Procedure:
• conventional technique
the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.
• 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.
• 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.
• videolaryngoscope technique
Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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. — View Citation

Bong CL, Macachor JD, Hwang NC. Insertion of the nasogastric tube made easy. Anesthesiology. 2004 Jul;101(1):266. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in the first attempt and overall success rate	investigate the difference in the first attempt and overall success rate (with percentage) of different techniques for insertion of nasogastric tube.	participants will be followed to the starting from the NG tube insert through the nostril until the confirm to successful insertion into stomach.	No
Secondary	difference of the duration of insertion and complications during insertion	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.	No