Intubation; DifficultNCT02250521
McGRATH MAC Video Laryngoscope
A study testing McGrath MAC enhanced direct laryngoscope in people with Intubation; Difficult, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- McGrath MAC enhanced direct laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI < 50 kg/m2
- Two or more of the following inclusion criteria: Mallampati class: III-IV; Reduced mouth opening < 4 cm; Neck circumference > 40 cm for females and > 43 cm for males; Thyromental distance < 6 cm; Ratio of the patient's height to thyromental distance ≥ 23.5; Sternomental distance < 12 cm
Who cannot join
- BMI ≥ 50 kg/m2
- emergency status
- cervical injury or pathology
- neck irradiation
- known difficult airway
- risk of gastric aspiration
- hemodynamic instability
- requiring rapid sequence intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: McGRATH MAC Video Laryngoscope - To View or Not To View?
This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial during laryngoscopy and intubation.
- Conditions
- Intubation; Difficult
- Being tested
- McGrath MAC enhanced direct laryngoscope
- Keywords
- BMI < 50 kg/m2, Mallampatti class: III-IV, Reduced mouth opening < 4 cm, Neck circumference > 40 cm for females and > 43 cm for males, Thyromental distance < 6 cm, Ratio of the patient's height to thyromental distance ≥ 23.5, Sternomental distance < 12 cm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath MAC enhanced direct laryngoscopeDevice
The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view.
All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| McGrath Mac intubations | Experimental | All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. Receives: Device: McGrath MAC enhanced direct laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View
All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
Measured: after successful endotracheal tube placement
Secondary outcomes (10)
Glottic View With Direct Laryngoscopy
Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible
Measured: at the time of laryngoscopy
Glottic View With Indirect Laryngoscopy
Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible
Measured: at the time of laryngoscopy
Time for Direct View Laryngoscopy During the First Attempt
Time from mouth opening to best direct laryngoscopic view
Measured: at the time of laryngoscopy
Time for Indirect View Laryngoscopy During the First Attempt
Time from mouth opening to best indirect laryngoscopic view
Measured: at the time of laryngoscopy
Time for Intubation
Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.
Measured: at the time of laryngoscopy
Number of Intubation Attempts
Measured: at the time of intubation
Number of Participants Who Received External Laryngeal Manipulation During the First Attempt
Measured: at the time of intubation
Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt
Measured: at the time of intubation
Subjective Ease of Laryngoscopy
The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained.
Measured: at the time of laryngoscopy
Subjective Ease of Intubation
The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords.
Measured: at the time of laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
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 Intubation; DifficultStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Carin A Hagberg, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250521
- Sponsor's protocol ID
- HSC-MS-14-0365
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2014
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- McGRATH MAC Video Laryngoscope - To View or Not To View?
- ClinicalTrials.gov ID
- NCT02250521
- Acronym / sponsor ID
- HSC-MS-14-0365
- Conditions
- Intubation; Difficult
- Keywords
- BMI < 50 kg/m2, Mallampatti class: III-IV, Reduced mouth opening < 4 cm, Neck circumference > 40 cm for females and > 43 cm for males, Thyromental distance < 6 cm, Ratio of the patient's height to thyromental distance ≥ 23.5, Sternomental distance < 12 cm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 9 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial during laryngoscopy and intubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| McGrath Mac intubations | Experimental | Device: McGrath MAC enhanced direct laryngoscopeAll 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI < 50 kg/m2
- Two or more of the following inclusion criteria: Mallampati class: III-IV; Reduced mouth opening < 4 cm; Neck circumference > 40 cm for females and > 43 cm for males; Thyromental distance < 6 cm; Ratio of the patient's height to thyromental distance ≥ 23.5; Sternomental distance < 12 cm
Key exclusion criteria (8 listed)
- BMI ≥ 50 kg/m2
- emergency status
- cervical injury or pathology
- neck irradiation
- known difficult airway
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 |
|---|---|---|
| McGrath MAC enhanced direct laryngoscopeThe McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view. All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist. | Device | McGrath Mac intubations |
Primary outcome
Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View
Time frame: after successful endotracheal tube placement
All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
10 secondary outcomes
Glottic View With Direct Laryngoscopy
Time frame: at the time of laryngoscopy
Glottic View With Indirect Laryngoscopy
Time frame: at the time of laryngoscopy
Time for Direct View Laryngoscopy During the First Attempt
Time frame: at the time of laryngoscopy
Time for Indirect View Laryngoscopy During the First Attempt
Time frame: at the time of laryngoscopy
Time for Intubation
Time frame: at the time of laryngoscopy
Number of Intubation Attempts
Time frame: at the time of intubation
Number of Participants Who Received External Laryngeal Manipulation During the First Attempt
Time frame: at the time of intubation
Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt
Time frame: at the time of intubation
Subjective Ease of Laryngoscopy
Time frame: at the time of laryngoscopy
Subjective Ease of Intubation
Time frame: at the time of laryngoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Device informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Intubation; Difficult
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
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.
Carin A Hagberg, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGrath MAC enhanced direct laryngoscope in people with Intubation; Difficult, run by The University of Texas Health Science Center, Houston 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 8 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 9 Nov 2018. 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 9 Nov 2018). 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?
Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View (time frame: after successful endotracheal tube placement). 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 9 Nov 2018.