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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04857190
Other study ID # DTH: 21001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date March 15, 2022

Study information

Verified date April 2021
Source Damanhour Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Damanhour Teaching Hospital Damanhur El-Beheira

Sponsors (1)

Lead Sponsor Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean and Standard deviation of Total time required for orotracheal intubation (seconds) (mean±SD) 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 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Mean and Standard deviation of Number of intubation attempts (mean±SD) An attempt is the act of inserting and removing the blade of the laryngoscope from the mouth 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Number of participants and Rate of Successful intubation from the first-attempt First-attempt intubation success rate 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Number of participants and Rate of Use of external laryngeal manipulation Number of participants and Rate of Use of external laryngeal manipulation 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Mean and Standard deviation of Heart rate (beat/min.)(mean±SD) Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Mean and Standard deviation of Oxygen Saturation (%)(mean±SD) Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD) Before, after induction, and 2 minutes after inserting the blade of the laryngoscope in the mouth 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary Number of participants and Rate of Procedure-related complications Number of participants and Rate of: Tachycardia, Dysrhythmia, Hypoxemia, Hypertension, Laryngospasm, Bronchospasm, Oropharyngeal trauma 5 minutes after the end of the procedure
See also
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