- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414839
Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy (NGT)
Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy Methods During Nasogastric Tube Insertion in Intubated Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Isfahan, Iran, Islamic Republic of, 8138938728
- Al-Zahra University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate
Time Frame: 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
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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.)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insertion duration
Time Frame: 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
|
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.)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 397585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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