LarynxETTNCT01263873
Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Endotracheal Tube
A study testing Mallinckrodt (ETT) and Parker Flex-Tip (ETT) in people with Larynx, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to determine if there are differences related to ease of intubation reported by clinicians who use the Parker Flex-Tip® endotracheal tubes(ETT)compared to the standard Mallinckrodt® (ETT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Larynx
- What is being tested?
- Mallinckrodt (ETT) and Parker Flex-Tip (ETT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects that are males and non-pregnant females > or equal to 18 years of age that require a general anesthetic with an (ETT).
- Able to give informed consent (adults, English reading and speaking)
Who cannot join
- Any subject on examination with a mallampati III or greater and/or history of difficult intubation.
- Any subject with an American Society of Anesthesiologist classification greater than 3.
- Any subject needing rapid sequence induction.
- Any subject that the anesthesia provider considers the GlideScope® to be contraindicated.
- Any subject that an anesthesia provider feels for any reason at any time is not appropriate for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Mallinckrodt® Endotracheal When Using the Glidescope®
The purpose of the study is to determine if there are differences related to ease of intubation reported by clinicians who use the Parker Flex-Tip® endotracheal tubes(ETT)compared to the standard Mallinckrodt® (ETT). The problem is two (ETTs), the Parker Flex-Tip® and the Mallinckrodt®, are currently available for use in operative suites for intubation, but few studies have compared these devices with each other. Two research questions to be answered in the study are 1. Is there a difference in the ease of intubation when the Parker Flex-Tip® (ETT) is used when compared to the standard Mallinckrodt® (ETT)? and 2. Are there differences in the number of successful intubations when comparing the Parker Flex-Tip® (ETT) and the standard Mallinckrodt® (ETT)? The hypotheses are the use of the Parker Flex-Tip® (ETT) will demonstrate: 1. Fewer seconds to intubate the trachea. 2. Higher self-reported ease of placement scores and 3. Fewer redirections to intubate the trachea. The number of successful intubations is expected to be the same in both arms of the study.
Read the detailed description
There are not many different types of (ETT)s with different ends or tips. The standard (ETT) by Mallinckrodt® is a disposable polyvinyl chloride plastic tube that has one hooded Murphy tip eye at the end of the tube. The Murphy tip eye is to help with ventilation and air passage if the main end is occluded with mucus or a foreign body. Another type of (ETT) is the Parker Flex-Tip® (ETT), which has a soft flex-tip that is configured to pass easily through the airway anatomy and has two Murphy tip eyes. Currently there are no published data comparing the Parker Flex-Tip® (ETT) with standard Mallinckrodt® (ETT) when the GlideScope® is used. The data are limited concerning the ease of intubation when using the Parker Flex-Tip® (ETT). The study is a two-factor randomized block intervention study design. Subjects assigned to the first group will be intubated using the standard Mallinckrodt® (ETT). The subjects assigned to the second group will be intubated using the Parker Flex-Tip® (ETT). Randomization will be accomplished using the sealed envelope technique. There are six anesthesia providers who will be using ETTs to intubate. A block design will be used to make sure each anesthesia provider receives the same number of patients randomized to the Mallinckrodt and to the Parker Flex-Tip® (ETT)s.
- Conditions
- Larynx
- Being tested
- Mallinckrodt (ETT), Parker Flex-Tip (ETT)
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mallinckrodt (ETT)Device
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
Parker Flex-Tip (ETT)Device
7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
| Study group | Role | What they receive |
|---|---|---|
| Mallinckrodt (ETT) | Active comparator | Artifical Airway Device Receives: Device: Mallinckrodt (ETT) |
| Parker Flex Tip (ETT) | Experimental | Artifical Airway Device Receives: Device: Parker Flex-Tip (ETT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Intubation, as Measured by Time in Seconds for ETT Insertion
To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).
Measured: Participants were followed for the duration of intubation, an average of 10 minutes
Ease of Intubation, as Measured by Number of ETT Redirections
To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.
Measured: Participants were followed for the duration of intubation, an average of 10 minutes
Ease of Intubation, as Measured by an Ease of ETT Insertion Score.
To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.
Measured: Participants were followed for the duration of intubation, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LarynxStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Radesic, University Hospitals Cleveland Medical Center
- Investigators
- Brian P Radesic, DNP, CRNA, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263873
- Sponsor's protocol ID
- 04-10-05
- Acronym
- ETT
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2010
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Ease of Intubation Using the Parker Flex-Tip® or a Standard Mallinckrodt® Endotracheal When Using the Glidescope®
- ClinicalTrials.gov ID
- NCT01263873
- Acronym / sponsor ID
- ETT / 04-10-05
- Conditions
- Larynx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Posted 19 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if there are differences related to ease of intubation reported by clinicians who use the Parker Flex-Tip® endotracheal tubes(ETT)compared to the standard Mallinckrodt® (ETT). The problem is two (ETTs), the Parker Flex-Tip® and the Mallinckrodt®, are currently available for use in operative suites for intubation, but few studies have compared these devices with each other. Two research questions to be answered in the study are 1. Is there a difference in the ease of intubation when the Parker Flex-Tip® (ETT) is used when compared to the standard Mallinckrodt® (ETT)? and 2. Are there differences in the number of successful intubations when comparing the Parker Flex-Tip® (ETT) and the standard Mallinckrodt® (ETT)? The hypotheses are the use of the Parker Flex-Tip® (ETT) will demonstrate: 1. Fewer seconds to intubate the trachea. 2. Higher self-reported ease of placement scores and 3. Fewer redirections to intubate the trachea. The number of successful intubations is expected to be the same in both arms of the study.
Detailed description
There are not many different types of (ETT)s with different ends or tips. The standard (ETT) by Mallinckrodt® is a disposable polyvinyl chloride plastic tube that has one hooded Murphy tip eye at the end of the tube. The Murphy tip eye is to help with ventilation and air passage if the main end is occluded with mucus or a foreign body. Another type of (ETT) is the Parker Flex-Tip® (ETT), which has a soft flex-tip that is configured to pass easily through the airway anatomy and has two Murphy tip eyes. Currently there are no published data comparing the Parker Flex-Tip® (ETT) with standard Mallinckrodt® (ETT) when the GlideScope® is used. The data are limited concerning the ease of intubation when using the Parker Flex-Tip® (ETT). The study is a two-factor randomized block intervention study design. Subjects assigned to the first group will be intubated using the standard Mallinckrodt® (ETT). The subjects assigned to the second group will be intubated using the Parker Flex-Tip® (ETT). Randomization will be accomplished using the sealed envelope technique. There are six anesthesia providers who will be using ETTs to intubate. A block design will be used to make sure each anesthesia provider receives the same number of patients randomized to the Mallinckrodt and to the Parker Flex-Tip® (ETT)s.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mallinckrodt (ETT) | Active comparator | Device: Mallinckrodt (ETT)Artifical Airway Device |
| Parker Flex Tip (ETT) | Experimental | Device: Parker Flex-Tip (ETT)Artifical Airway Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects that are males and non-pregnant females > or equal to 18 years of age that require a general anesthetic with an (ETT).
- Able to give informed consent (adults, English reading and speaking)
Key exclusion criteria (5 listed)
- Any subject on examination with a mallampati III or greater and/or history of difficult intubation.
- Any subject with an American Society of Anesthesiologist classification greater than 3.
- Any subject needing rapid sequence induction.
- Any subject that the anesthesia provider considers the GlideScope® to be contraindicated.
- Any subject that an anesthesia provider feels for any reason at any time is not appropriate for inclusion in this study.
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 |
|---|---|---|
| Mallinckrodt (ETT)7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male | Device | Mallinckrodt (ETT) |
| Parker Flex-Tip (ETT)7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male | Device | Parker Flex Tip (ETT) |
Primary outcome
Ease of Intubation, as Measured by Time in Seconds for ETT Insertion
Time frame: Participants were followed for the duration of intubation, an average of 10 minutes
To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).
Ease of Intubation, as Measured by Number of ETT Redirections
Time frame: Participants were followed for the duration of intubation, an average of 10 minutes
To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.
Ease of Intubation, as Measured by an Ease of ETT Insertion Score.
Time frame: Participants were followed for the duration of intubation, an average of 10 minutes
To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Parker Flex tip endotracheal tubeLink provided by the sponsor.
Related trials for Larynx
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
RecruitingPhase 2/3
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
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.
Brian P Radesic, DNP, CRNA principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mallinckrodt (ETT) and Parker Flex-Tip (ETT) in people with Larynx, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 2 inclusion and 5 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 17 Dec 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ease of Intubation, as Measured by Time in Seconds for ETT Insertion (time frame: Participants were followed for the duration of intubation, an average of 10 minutes). The study lists 3 primary outcomes in all. 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 17 Dec 2014.