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

NCT ID: NCT03134287

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube Placement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

two-finger method

Those who received nasogastric tube placement by two-finger method

Group Type ACTIVE_COMPARATOR

two-finger method, reverse sellick's method

Intervention Type PROCEDURE

Subjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method

reverse sellick's method

Those who received nasogastric tube placement by reverse sellick's method

Group Type ACTIVE_COMPARATOR

two-finger method, reverse sellick's method

Intervention Type PROCEDURE

Subjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. dr. Aida Rosita Tantri SpAn-KA

Anesthesiologist Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

Sinha PK, Koshy T. Reverse Sellick's maneuver for transesophageal echocardiographic probe placement. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):626-8. doi: 10.1053/j.jvca.2006.10.010. Epub 2007 Jan 9. No abstract available.

Reference Type BACKGROUND
PMID: 17678806 (View on PubMed)

Ratzlaff HC, Heaslip JE, Rothwell ES. Factors affecting nasogastric tube insertion. Crit Care Med. 1984 Jan;12(1):52-3. doi: 10.1097/00003246-198401000-00014.

Reference Type BACKGROUND
PMID: 6690206 (View on PubMed)

Ozer S, Benumof JL. Oro- and nasogastric tube passage in intubated patients: fiberoptic description of where they go at the laryngeal level and how to make them enter the esophagus. Anesthesiology. 1999 Jul;91(1):137-43. doi: 10.1097/00000542-199907000-00022.

Reference Type BACKGROUND
PMID: 10422939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22104075 (View on PubMed)

Agarwal A, Gaur A, Sahu D, Singh PK, Pandey CK. Nasogastric tube knotting over the epiglottis: a cause of respiratory distress. Anesth Analg. 2002 Jun;94(6):1659-60, table of contents. doi: 10.1097/00000539-200206000-00056.

Reference Type BACKGROUND
PMID: 12032048 (View on PubMed)

Cataldi-Betcher EL, Seltzer MH, Slocum BA, Jones KW. Complications occurring during enteral nutrition support: a prospective study. JPEN J Parenter Enteral Nutr. 1983 Nov-Dec;7(6):546-52. doi: 10.1177/0148607183007006546.

Reference Type BACKGROUND
PMID: 6418910 (View on PubMed)

Noguchi T, Shiga Y, Koga K, Shigematsu A. A method to improve a gas leak on mask ventilation in the patient with a nasogastric tube. Anesthesiology. 2001 Mar;94(3):545. doi: 10.1097/00000542-200103000-00041. No abstract available.

Reference Type BACKGROUND
PMID: 11374627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19690254 (View on PubMed)

Mahajan R, Gupta R, Sharma A. Role of neck flexion in facilitating nasogastric tube insertion. Anesthesiology. 2005 Aug;103(2):446-7. doi: 10.1097/00000542-200508000-00034. No abstract available.

Reference Type BACKGROUND
PMID: 16052133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19626360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19861362 (View on PubMed)

Perel A, Ya'ari Y, Pizov R. Forward displacement of the larynx for nasogastric tube insertion in intubated patients. Crit Care Med. 1985 Mar;13(3):204-5. doi: 10.1097/00003246-198503000-00013.

Reference Type BACKGROUND
PMID: 3971730 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Textbook

Samuels LE, Roberts JR, Hedges JR. Nasogastric and Feeding Tube Placement, In: Clinical Procedures in Emergency Medicine. 4th ed. WB Saunders; 2004. p784-804.

View Document

Document Type: Textbook

Irwin RS, Rippe JM. Irwin and Rippe's Intensive Care Medicine: Endoscopic Placement of Feeding Tubes. 6th ed. Lippincott Williams \& Wilkins; 2008. p145-150.

View Document

Document Type: Textbook

Marino PL. Enteral Tube Feeding. In: The ICU Book. 3rd ed. Lippincott Williams \& Wilkins; 2007. p842-855.

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://jcvtr.tbzmed.ac.ir/common/files_pdf/2009-11-24-8-0-43.pdf

Fakhari S, Bilehjani I, Negargar S. Split Endotracheal Tube as a Guide Tube for Gastric Tube Insertion in Anesthetized Patients: A Randomized Clinical Trial. In: Journal of Cardiovascular and Thoracic Research; 2009. vol. 1. p17-22.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IndonesiaUAnes013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Facilitation of NGT Insertion
NCT02764632 COMPLETED NA