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

NCT ID: NCT04857190

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-03-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group DS (n=40)

Parker Flex-it Directional Stylet group

Group Type: ACTIVE_COMPARATOR

Parker Flex-it Directional Stylet

Intervention Type: DEVICE

Parker Flex-it Directional Stylet

Group MS (n=40)

Conventional Malleable Stylet group

Group Type: ACTIVE_COMPARATOR

Conventional Malleable Stylet

Intervention Type: DEVICE

Conventional Malleable Stylet

Interventions

Parker Flex-it Directional Stylet

Parker Flex-it Directional Stylet

Intervention Type: DEVICE

Conventional Malleable Stylet

Conventional Malleable Stylet

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Countries

Egypt

Other Identifiers

DTH: 21001

Identifier Type: -

Identifier Source: org_study_id