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

NCT ID: NCT04414839

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-05-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Digital Intubation (Two-finger)

Group Type: ACTIVE_COMPARATOR

Digital Intubation (Two-finger)

Intervention Type: 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.

Video Laryngoscopy

Group Type: ACTIVE_COMPARATOR

Video Laryngoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Nasr Isfahani

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Zahra University Hospital

Isfahan, , Iran

Countries

Iran

Other Identifiers

397585

Identifier Type: -

Identifier Source: org_study_id