Clinical trial NCT04857190: Parker Flex-it Stylet Versus Malleable Stylet in Orotracheal Intubation Using a Fiber-optic Laryngoscope
Official title: Parker Flex-it Directional Stylet Versus Conventional Malleable Stylet in Elective Orotracheal Intubation Using a Fiber-optic Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orotracheal Intubation
Keywords: Conventional Malleable Stylet
Orotracheal Intubation
Parker Flex-it Directional Stylet
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Mean and Standard deviation of Time required for orotracheal intubation (seconds) (mean±SD)
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary outcomes:
measure: Mean and Standard deviation of Total time required for orotracheal intubation (seconds) (mean±SD)
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Mean and Standard deviation of Number of intubation attempts (mean±SD)
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Number of participants and Rate of Successful intubation from the first-attempt
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Number of participants and Rate of Use of external laryngeal manipulation
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Mean and Standard deviation of Oxygen Saturation (%)(mean±SD)
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)
timeFrame: 2 minutes after inserting the blade of the laryngoscope in the mouth
measure: Number of participants and Rate of Procedure-related complications
timeFrame: 5 minutes after the end of the procedure
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References: