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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04414839
Other study ID # 397585
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date May 15, 2020

Study information

Verified date June 2020
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date May 15, 2020
Est. primary completion date March 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Iran, Islamic Republic of Al-Zahra University Hospital Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Insertion duration Measuring how long will it last to insert successfully an NG tube 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.)
See also
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Recruiting NCT03508401 - Transthoracic Echocardiography of the Superior Vena Cava in Intensive Care Units (ICU) Intubated Patients N/A
Recruiting NCT05416489 - C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy N/A