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

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ClinicalTrials.gov Identifier: NCT03134287
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University

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

Condition or disease Intervention/treatment Phase
Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube Placement Procedure: two-finger method, reverse sellick's method Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Feasibility of Nasogastric Tube Placement on Intubated Patient: Comparison Between Two-Finger Method and Reverse Sellick's Maneuver
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 31, 2017

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




Primary Outcome Measures :
  1. Successful rate [ Time Frame: Day 1 ]
    Successful rate on nasogastric tube placement in first attempt


Secondary Outcome Measures :
  1. Time [ Time Frame: Day 1 ]
    Time needed to insert the nasogastric tube

  2. Complications [ Time Frame: Day 1 ]
    Complications occurred during procedure



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134287


Locations
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Indonesia
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

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

Publications:

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Responsible Party: Dr. dr. Aida Rosita Tantri SpAn-KA, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03134287     History of Changes
Other Study ID Numbers: IndonesiaUAnes013
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No