NGT: Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04414839
Collaborator
(none)
76
1
2
23.5
3.2

Study Details

Study Description

Brief Summary

Abstract Background: A number of patients referring to the emergency departments (EDs) due to airway obstruction or decreased level of consciousness require the establishment of a definite airway using intubation. On the other hand, performing Nasogastric tube (NGT) insertion is very challenging in anesthetized and intubated patients. And, a conclusive method has not yet been presented in this regard. Hence, the current study aimed at comparing Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.

Materials and Methods: The present clinical trial was performed on 76 intubated patients that were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients' satisfaction level were recorded and examined in this study.

Condition or Disease Intervention/Treatment Phase
  • Device: Digital Intubation (Two-finger)
  • Device: Video Laryngoscopy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy Methods During Nasogastric Tube Insertion in Intubated Patients
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Mar 20, 2020
Actual Study Completion Date :
May 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Digital Intubation (Two-finger)

Device: Digital Intubation (Two-finger)
In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion.

Active Comparator: Video Laryngoscopy

Device: Video Laryngoscopy
In the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation.

Outcome Measures

Primary Outcome Measures

  1. Success rate [Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)]

    being successfully inserted into the stomach

Secondary Outcome Measures

  1. Insertion duration [Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)]

    Measuring how long will it last to insert successfully an NG tube into the stomach

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18-65 year old patients that underwent rapid sequence intubation (RSI) and required NGT insertion
Exclusion Criteria:
  • having skull base fracture symptoms

  • coagulopathy and hemorrhagic disorders

  • maxillofacial traumas leading to the deformity and disturbance in NGT insertion

  • diseases and anomalies of the upper respiratory tract

  • deviated nasal septum

  • nostril stenosis

  • esophageal disorders (esophageal stricture, esophageal varices)

  • a history of head and neck radiotherapy, and

  • patients intubated in and transferred from other centers

  • patients with more than two unsuccessful attempts at NGT insertion were excluded from the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-Zahra University Hospital Isfahan Iran, Islamic Republic of 8138938728

Sponsors and Collaborators

  • Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mehdi Nasr Isfahani, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04414839
Other Study ID Numbers:
  • 397585
First Posted:
Jun 4, 2020
Last Update Posted:
Jun 4, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mehdi Nasr Isfahani, Dr., Isfahan University of Medical Sciences

Study Results

No Results Posted as of Jun 4, 2020