Orotracheal IntubationNCT04857190
Parker Flex-it Stylet Versus Malleable Stylet in Orotracheal Intubation Using a Fiber-optic Laryngoscope
A study testing Parker Flex-it Directional Stylet and Conventional Malleable Stylet in people with Orotracheal Intubation, run by Damanhour Teaching Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Orotracheal Intubation
- What is being tested?
- Parker Flex-it Directional Stylet and Conventional Malleable Stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35
- Mallampati classification ≤ II
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Parker Flex-it Directional Stylet Versus Conventional Malleable Stylet in Elective 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.
- Conditions
- Orotracheal Intubation
- Being tested
- Parker Flex-it Directional Stylet, Conventional Malleable Stylet
- Keywords
- Conventional Malleable Stylet, Orotracheal Intubation, Parker Flex-it Directional Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parker Flex-it Directional StyletDevice
Parker Flex-it Directional Stylet
Conventional Malleable StyletDevice
Conventional Malleable Stylet
| Study group | Role | What they receive |
|---|---|---|
| Group DS (n=40) | Active comparator | Parker Flex-it Directional Stylet group Receives: Device: Parker Flex-it Directional Stylet |
| Group MS (n=40) | Active comparator | Conventional Malleable Stylet group Receives: Device: Conventional Malleable Stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
Secondary outcomes (8)
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
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
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
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
Number of participants and Rate of Successful intubation from the first-attempt
First-attempt intubation success rate
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
Number of participants and Rate of Use of external laryngeal manipulation
Number of participants and Rate of Use of external laryngeal manipulation
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
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
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
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
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
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
Measured: 2 minutes after inserting the blade of the laryngoscope in the mouth
Number of participants and Rate of Procedure-related complications
Number of participants and Rate of: Tachycardia, Dysrhythmia, Hypoxemia, Hypertension, Laryngospasm, Bronchospasm, Oropharyngeal trauma
Measured: 5 minutes after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 May 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orotracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857190
- Sponsor's protocol ID
- DTH: 21001
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parker Flex-it Directional Stylet Versus Conventional Malleable Stylet in Elective Orotracheal Intubation Using a Fiber-optic Laryngoscope
- ClinicalTrials.gov ID
- NCT04857190
- Acronym / sponsor ID
- DTH: 21001
- Conditions
- Orotracheal Intubation
- Keywords
- Conventional Malleable Stylet, Orotracheal Intubation, Parker Flex-it Directional Stylet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DS (n=40) | Active comparator | Device: Parker Flex-it Directional StyletParker Flex-it Directional Stylet group |
| Group MS (n=40) | Active comparator | Device: Conventional Malleable StyletConventional Malleable Stylet group |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35
- Mallampati classification ≤ II
Key exclusion criteria (11 listed)
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Mallampati classification > II
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parker Flex-it Directional StyletParker Flex-it Directional Stylet | Device | Group DS (n=40) |
| Conventional Malleable StyletConventional Malleable Stylet | Device | Group MS (n=40) |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
Mean and Standard deviation of Oxygen Saturation (%)(mean±SD)
Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth
Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)
Time frame: 2 minutes after inserting the blade of the laryngoscope in the mouth
Number of participants and Rate of Procedure-related complications
Time frame: 5 minutes after the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
Related trials for Orotracheal Intubation
RecruitingObservational study
Prevalence of Tapia's Syndrome in Weaning Unit
Tapia's Syndrome
RecruitingObservational study
Tracheal Cuff Pressure and Postoperative Complications
Tracheal Intubation, Postoperative Complications (Cardiopulmonary)
Not yet recruiting
Development and Application of an Oral Care Protocol for Stroke Patients With Orotracheal Intubation
Develop an Oral Care Plan and Verify it
Recruiting
Pilot Study on the Use of Video Laryngoscopy in Pre-hospital Settings
Emergency, Orotracheal Intubation
Not yet recruiting
AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients
Orotracheal Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parker Flex-it Directional Stylet and Conventional Malleable Stylet in people with Orotracheal Intubation, run by Damanhour Teaching Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.