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

NCT04414839 | Completed DMC

• 1 other identifier: 397585
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubated Patients

Keywords

Digital Laryngoscopy; Endotracheal Tube; Nasogastric Tube (NGT); Video Laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Success rate

  being successfully inserted into the stomach

  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.)

Secondary Outcomes (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.)

Study Arms (2)

Digital Intubation (Two-finger)

ACTIVE COMPARATOR

Device: Digital Intubation (Two-finger)

Video Laryngoscopy

ACTIVE COMPARATOR

Device: Video Laryngoscopy

Interventions

Digital Intubation (Two-finger) DEVICE

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.

Digital Intubation (Two-finger)

Video Laryngoscopy DEVICE

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.

Video Laryngoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old patients that underwent rapid sequence intubation (RSI) and required NGT insertion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Al-Zahra University Hospital

Isfahan, 8138938728, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2018
• Primary Completion: March 20, 2020
• Study Completion: May 15, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

IR (1)