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

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

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.

Study Overview

• Status: Completed
• Conditions: Orotracheal Intubation
• Intervention / Treatment: Device: Parker Flex-it Directional Stylet; Device: Conventional Malleable Stylet

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Beheira
    • Damanhūr, El-Beheira, Egypt
      • Damanhour Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Damanhour Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Conventional Malleable Stylet; Orotracheal Intubation; Parker Flex-it Directional Stylet
• Other Study ID Numbers: DTH: 21001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No