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

NCT04857190 | Completed

• 1 other identifier: DTH: 21001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orotracheal Intubation

Keywords

Conventional Malleable Stylet; Orotracheal Intubation; Parker Flex-it Directional Stylet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean and Standard deviation of Total time required for orotracheal intubation (seconds) (mean±SD)

  2 minutes after inserting the blade of the laryngoscope in the mouth

• Mean and Standard deviation of Number of intubation attempts (mean±SD)

  2 minutes after inserting the blade of the laryngoscope in the mouth

• Number of participants and Rate of Successful intubation from the first-attempt

  2 minutes after inserting the blade of the laryngoscope in the mouth

• 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)

  2 minutes after inserting the blade of the laryngoscope in the mouth

Study Arms (2)

Group DS (n=40)

ACTIVE COMPARATOR

Parker Flex-it Directional Stylet group

Device: Parker Flex-it Directional Stylet

Group MS (n=40)

ACTIVE COMPARATOR

Conventional Malleable Stylet group

Device: Conventional Malleable Stylet

Interventions

Parker Flex-it Directional Stylet DEVICE

Parker Flex-it Directional Stylet

Group DS (n=40)

Conventional Malleable Stylet DEVICE

Conventional Malleable Stylet

Group MS (n=40)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status ≤ II
• Age from 21 to 60 years
• Body Mass Index (BMI) \< 35
• Mallampati classification ≤ II

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour Teaching Hospital: lead

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

Study Officials

• Ahmed M Shaat, MD

  Damanhour Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: May 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 22, 2022

Record last verified: 2021-04

Locations

EG (1)