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Completed

NCT Number: NCT04857190

Parker Flex-it Stylet Versus Malleable Stylet in 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.

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Key information

Conditions

Orotracheal Intubation

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parker Flex-it Directional Stylet

Device

Parker Flex-it Directional Stylet

Conventional Malleable Stylet

Device

Conventional Malleable Stylet

Primary outcomes

  1. Mean and Standard deviation of Time required for orotracheal intubation (seconds) (mean±SD)

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    Time interval from holding the endotracheal tube by the anesthetist till removal of the stylet from the endotracheal tube by the anesthetist

Secondary outcomes

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

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

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

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    An attempt is the act of inserting and removing the blade of the laryngoscope from the mouth

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

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    First-attempt intubation success rate

  4. Number of participants and Rate of Use of external laryngeal manipulation

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    Number of participants and Rate of Use of external laryngeal manipulation

  5. Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth

  6. Mean and Standard deviation of Oxygen Saturation (%)(mean±SD)

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth

  7. Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)

    Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth

    Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth

  8. Number of participants and Rate of Procedure-related complications

    Time frame: 5 minutes after the end of the procedure

    Number of participants and Rate of: Tachycardia, Dysrhythmia, Hypoxemia, Hypertension, Laryngospasm, Bronchospasm, Oropharyngeal trauma

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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