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

Damanhour Teaching Hospital

Status: Completed

Conditions: Orotracheal Intubation

Treatments: Device: Conventional Malleable Stylet; Device: Parker Flex-it Directional Stylet

Study type: Interventional

Funder types: Other

Identifiers

NCT04857190

DTH: 21001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group DS (n=40)

Active Comparator group

Description:

Parker Flex-it Directional Stylet group

Treatment:

Device: Parker Flex-it Directional Stylet

Group MS (n=40)

Active Comparator group

Description:

Conventional Malleable Stylet group

Treatment:

Device: Conventional Malleable Stylet