NCT02557204

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

September 17, 2015

Last Update Submit

December 6, 2015

Conditions

Keywords

nasogastric tube insertionVideo laryngoscopesuccess rate

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • difference of the duration of insertion and complications during insertion

    participants will be followed for the duration of intraoperative period and postoperative 4 hours.

Study Arms (4)

conventional technique

ACTIVE COMPARATOR

the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.

Procedure: conventional technique

head in the lateral position technique

EXPERIMENTAL

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.

Procedure: head in the lateral position technique

endotracheal tube assisted technique

EXPERIMENTAL

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.

Procedure: endotracheal tube assisted technique

videolaryngoscope technique

EXPERIMENTAL

Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.

Procedure: videolaryngoscope technique

Interventions

the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.

conventional 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.

head in the lateral position 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.

endotracheal tube assisted technique

Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.

videolaryngoscope technique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received general anaesthesia for elective abdominal surgeries that required nasogastric tube insertion.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

    PMID: 22104075BACKGROUND
  • 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.

    PMID: 19861362BACKGROUND
  • 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.

    PMID: 19690254BACKGROUND
  • 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.

    PMID: 25435406BACKGROUND
  • 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.

    PMID: 19626360BACKGROUND
  • 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.

    PMID: 15220819BACKGROUND
  • 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.

    PMID: 23378961BACKGROUND
  • 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.

    PMID: 22853453BACKGROUND
  • 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.

    PMID: 25278810BACKGROUND
  • 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.

    PMID: 24188942BACKGROUND
  • 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.

    PMID: 25900711BACKGROUND
  • 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.

    PMID: 20978245BACKGROUND

Study Officials

  • Ali S Kavakli, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 23, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations