Parker Flex-it Stylet Versus Malleable Stylet in Orotracheal Intubation Using a Fiber-optic Laryngoscope

Study Overview
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Brief Summary
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Objectives: To compare the safety and efficacy of Parker flex-it directional stylet (PFDS) versus conventional malleable stylet (CMS) in orotracheal intubation (OTI) using fiber-optic Macintosh laryngoscope. Background: OTI is used in general anesthesia for anesthetic delivery and ventilation of patients. OTI delay or failure may adversely affect patient outcomes, therefore, anesthetists with sufficient clinical experience and skill should perform OTI. However, in emergency situations, experienced anesthetists may not be available, and the patient may have a high Cormack-Lehane grade. A stylet is commonly used in the emergency department to aid insertion of the endotracheal tube during direct laryngoscopy. Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 80 patients requiring OTI under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group DS, intubated using PFDS, and group MS, intubated using CMS.

Official Title
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Parker Flex-it Directional Stylet Versus Conventional Malleable Stylet in Elective Orotracheal Intubation Using a Fiber-optic Laryngoscope

Conditions
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Orotracheal Intubation

Intervention / Treatment
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* Device: Parker Flex-it Directional Stylet
* Device: Conventional Malleable Stylet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status ≤ II Age from 21 to 60 years Body Mass Index (BMI) < 35 Mallampati classification ≤ II Exclusion Criteria: American Society of Anesthesiologists (ASA) physical status > II Age < 21 years or > 60 years Body Mass Index (BMI) ≥ 35 Mallampati classification > II Pregnant women Anticipated difficult airway Need for rapid sequence induction Increased risk of gastric aspiration such as gastroesophageal reflux Edentulous patients, Loose teeth Known pathology, trauma, or previous surgery to the mouth, pharynx, larynx, or cervical spine History of; Dysrhythmia, Hypertension, Ischemic heart disease, Hyperthyroidism, DM

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group DS (n=40)<br>Parker Flex-it Directional Stylet group | Device: Parker Flex-it Directional Stylet<br>* Parker Flex-it Directional Stylet<br>|
| Active Comparator: Group MS (n=40)<br>Conventional Malleable Stylet group | Device: Conventional Malleable Stylet<br>* Conventional Malleable Stylet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and Standard deviation of Time required for orotracheal intubation (seconds) (mean±SD) | Time interval from holding the endotracheal tube by the anesthetist till removal of the stylet from the endotracheal tube by the anesthetist | 2 minutes after inserting the blade of the laryngoscope in the mouth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and Standard deviation of Total time required for orotracheal intubation (seconds) (mean±SD) | Time interval from inserting the blade of the laryngoscope into the patient's mouth till the appearance of end-tidal carbon dioxide curve of at least 30 mmHg on the anesthesia monitor after insertion of the endotracheal tube | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Mean and Standard deviation of Number of intubation attempts (mean±SD) | An attempt is the act of inserting and removing the blade of the laryngoscope from the mouth | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Number of participants and Rate of Successful intubation from the first-attempt | First-attempt intubation success rate | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Number of participants and Rate of Use of external laryngeal manipulation | Number of participants and Rate of Use of external laryngeal manipulation | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Mean and Standard deviation of Heart rate (beat/min.)(mean±SD) | Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Mean and Standard deviation of Oxygen Saturation (%)(mean±SD) | Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD) | Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth | 2 minutes after inserting the blade of the laryngoscope in the mouth | 
| Number of participants and Rate of Procedure-related complications | Number of participants and Rate of: Tachycardia, Dysrhythmia, Hypoxemia, Hypertension, Laryngospasm, Bronchospasm, Oropharyngeal trauma | 5 minutes after the end of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conventional Malleable Stylet, Orotracheal Intubation, Parker Flex-it Directional Stylet