Disorder of AbdomenNCT02557204

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

A study testing conventional technique, head in the lateral position technique and endotracheal tube assisted technique in people with Disorder of Abdomen, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Disorder of Abdomen
What is being tested?: conventional technique, head in the lateral position technique and endotracheal tube assisted technique
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Sep 2015to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Disorder of Abdomen
Being tested: conventional technique, head in the lateral position technique, endotracheal tube assisted technique, videolaryngoscope technique
Keywords: nasogastric tube insertion, Video laryngoscope, success rate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

conventional techniqueProcedure or surgery
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 techniqueProcedure or surgery
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 techniqueProcedure or surgery
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 techniqueProcedure or surgery
Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.

Study groups in NCT02557204
Study group	Role	What they receive
conventional technique	Active comparator	the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position. Receives: 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. Receives: 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. Receives: Procedure: endotracheal tube assisted technique
videolaryngoscope technique	Experimental	Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision. Receives: Procedure: videolaryngoscope technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Nov 2015

First posted23 Sep 2015 (estimated)
Study startSep 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Disorder of AbdomenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02557204
Sponsor's protocol ID: AntalyaTRH 007
Status last verified: Dec 2015
First submitted: 17 Sep 2015
Last updated: 8 Dec 2015
Results posted: No
Data monitoring committee: No

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.
PubMed 22104075
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.
PubMed 19861362
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.
PubMed 19690254
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.
PubMed 25435406
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.
PubMed 19626360
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.
PubMed 15220819
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.
PubMed 23378961
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.
PubMed 22853453
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.
PubMed 25278810
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.
PubMed 24188942
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.
PubMed 25900711
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.
PubMed 20978245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Disorder of Abdomen trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated Patients: A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02557204
Acronym / sponsor ID: AntalyaTRH 007
Conditions: Disorder of Abdomen
Keywords: nasogastric tube insertion, Video laryngoscope, success rate
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Antalya Training and Research HospitalOther government
Study start: Sep 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 23 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
conventional technique	Active comparator	Procedure: conventional techniquethe 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	Experimental	Procedure: head in the lateral position techniquethe 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	Experimental	Procedure: endotracheal tube assisted techniqueNasogastric 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	Experimental	Procedure: videolaryngoscope techniqueNasogastric tube was inserted transnasally and advanced into esophagus under direct vision.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

Patients with a history of coagulopathy,
nasal stenosis,
upper respiratory tract diseases or anomalies,
esophageal varix, esophageal hiatus hernia,
base of skull fracture,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
conventional techniquethe nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.	Procedure or surgery	conventional technique
head in the lateral position techniquethe 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 or surgery	head in the lateral position technique
endotracheal tube assisted techniqueNasogastric 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 or surgery	endotracheal tube assisted technique
videolaryngoscope techniqueNasogastric tube was inserted transnasally and advanced into esophagus under direct vision.	Procedure or surgery	videolaryngoscope technique

Primary outcome

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.

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
Background: PubMed 22104075Kirtania 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.
Background: PubMed 19861362Moharari 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.
Background: PubMed 19690254Appukutty 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.
Background: PubMed 25435406Kwon 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.
Background: PubMed 19626360Chun 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.
Background: PubMed 15220819Bong 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.
Background: PubMed 23378961Ghatak 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.
Background: PubMed 22853453Tsai 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.
Background: PubMed 25278810Okabe 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.
Background: PubMed 24188942Illias 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.
Background: PubMed 25900711Milsom 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.
Background: PubMed 20978245Halloran 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ali S Kavakli, MD study director

Antalya Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557204, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.