Nasogastric Tube Placement on Intubated Patient: Two-Finger Method vs Reverse Sellick's Maneuver

August 15, 2017 updated by: Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University

Feasibility of Nasogastric Tube Placement on Intubated Patient: Comparison Between Two-Finger Method and Reverse Sellick's Maneuver

The study aimed to compare the efficacy between nasogastric tube placement using Two-Finger Method and Reverse Sellick's Maneuver

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Two-Finger method group and Reverse Sellick's maneuver group). Intravenous (IV) cannula with isotonic fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. Vital signs were recorded. Midazolam 1-2 mg and Fentanyl 2 µg/kg body weight (BW) were given as premedication. Induction was performed using propofol 2-3 µg/kg BW. Rocuronium 0.5mg/kg BW was also given after induction. Two minimum alveolar concentration (MAC) of sevoflurane and 6 liter per minute of oxygen were also given using face mask for 3 minutes until the drugs took effect. Patient were then intubated. Evaluation of airway was performed to exclude the subjects who experienced airway trauma. Estimating the length of nasogastric tube was performed by stretching the nasogastric tube from xyphoid process through nose to the back of the ear. The measured number in cm then added with 15 cm and marked with tape. Nasogastric tube and the selected nostril then covered in gel sufficiently. The Two-Finger method group was placed with nasogastric tube using two-finger method, before the procedure, the endotracheal tube cuff was deflated first. And then the nasogastric tube was inserted into the selected nostril perpendicularly using dominant hand. The non-dominant hand (index and middle finger) was inserted to the base of oropharynx until the nasogastric tube was felt , and the the nasogastric tube was fixated in the middle position and the base of pharynx, as nearest as possible from esophagus, while the dominant hand pushed the nasogastric tube until it reached the mark. The reverse Sellick's maneuver group's endotracheal tube was also deflated before the procedure. The nasogastric tube was inserted into the selected nostril perpendicularly using dominant hand and pushed gently until it reached the first resistance in nasopharynx. Reverse Sellick's maneuver was performed using non-dominant hand, done by grabbing thyroid cartilage upward and elevated the larynx anteriorly, while the dominant hand kept pushing the nasogastric tube gently until it reached the mark. Evaluation whether or not the nasogastric tube was properly placed was using the auscultation method in the epigastric region and inserting air through catheter tip. Time and complications occurred during procedure were recorded. And the nasogastric tube was fixated if it was successfully inserted.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 18-60 years old, with American Society of Anesthesiologists (ASA) physical status of I-III who were planned to undergo any elective surgery at operating room in general anesthesia and needed nasogastric tube placement
  • subjects had been explained about the study, and agreed to enroll and have signed the informed consent form

Exclusion Criteria:

  • Subjects with possibility of difficult airway
  • multiple fracture in the head
  • craniofacial, airway, esophagus, and neck abnormality

Drop out Criteria:

  • Subjects who experience airway trauma during intubation or allergic reaction due to drugs used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: two-finger method
Those who received nasogastric tube placement by two-finger method
Procedure: two-finger method, reverse sellick's method
Subjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method
Active Comparator: reverse sellick's method
Those who received nasogastric tube placement by reverse sellick's method
Procedure: two-finger method, reverse sellick's method
Subjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful rate
Time Frame: Day 1
Successful rate on nasogastric tube placement in first attempt
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time
Time Frame: Day 1
Time needed to insert the nasogastric tube
Day 1
Complications
Time Frame: Day 1
Complications occurred during procedure
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IndonesiaUAnes013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Textbook
    Information comments: Samuels LE, Roberts JR, Hedges JR. Nasogastric and Feeding Tube Placement, In: Clinical Procedures in Emergency Medicine. 4th ed. WB Saunders; 2004. p784-804.
  2. Textbook
    Information comments: Irwin RS, Rippe JM. Irwin and Rippe's Intensive Care Medicine: Endoscopic Placement of Feeding Tubes. 6th ed. Lippincott Williams & Wilkins; 2008. p145-150.
  3. Textbook
    Information comments: Marino PL. Enteral Tube Feeding. In: The ICU Book. 3rd ed. Lippincott Williams & Wilkins; 2007. p842-855.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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