Intubation ComplicationGRAN-PALMNCT04509453
McGRATH vs Macintosh Laryngoscopy Comparison in LMA Insertion
A study testing McGRATH laryngoscopy and Macintosh laryngoscopy in people with Intubation Complication and Intubation;Difficult, run by Udayana University at 1 site in Indonesia.
Trial summary
Various techniques have been developed to get a good LMA position, one of them is using a laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation Complication, Intubation;Difficult, Anesthesia
- What is being tested?
- McGRATH laryngoscopy and Macintosh laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Aug 2020to 1 Nov 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent surgery with general anesthesia by LMA insertion in Sanglah General Hospital
- Agreed to be included in the study by signing informed consent
- American Society of Anesthesiologist physical status 1-2
Who cannot join
- Patients unfit for LMA insertion
- Patients with suspected airway management difficulty
- Pregnancy
- Morbid obese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between McGRATH and Macintosh Laryngoscopy in Laryngeal Mask Airway Insertion
Various techniques have been developed to get a good LMA position, one of them is using a laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type. Technological developments have brought laryngoscopes into the video era, one of which is McGRATH's laryngoscope, which from several studies about having an advantage in terms of the first attempt, time, complications, and hemodynamic stability of intubation. It needs to be proven through research on the comparison of clinical outcomes of LMA installation with McGrath laryngoscope and Macintosh laryngoscope.
- Conditions
- Intubation Complication, Intubation;Difficult, Anesthesia
- Being tested
- McGRATH laryngoscopy, Macintosh laryngoscopy
- Keywords
- successful intubation, classic LMA, video laryngoscopy, difficulty, cuff pressure leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGRATH laryngoscopyDevice
Also called Group G
Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy
Macintosh laryngoscopyDevice
Also called Group I
Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
| Study group | Role | What they receive |
|---|---|---|
| McGRATH | Experimental | Not described Receives: Device: McGRATH laryngoscopy; Device: Macintosh laryngoscopy |
| Macintosh | Active comparator | Not described Receives: Device: McGRATH laryngoscopy; Device: Macintosh laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with first-attempt success
Successful LMA insertion within first attempt
Measured: immediately after LMA insertion
Mean arterial pressure
Mean arterial pressure measured by non-invasive blood pressure monitor
Measured: immediately after LMA insertion
Heart rate
Heart rate measured by standard monitor
Measured: immediately after LMA insertion
Secondary outcomes (2)
Time required
Time required for LMA insertion using the respective method
Measured: immediately after LMA insertion
Complications
Incidence of hoarseness or throat pain due to LMA insertion
Measured: An hour after the the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start30 Aug 2020
- Primary completion30 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509453
- Sponsor's protocol ID
- UNUD-CTR-FK270720-003
- Other IDs
- 1320/UN14.2.2.VII.14/LT/2020
- Acronym
- GRAN-PALM
- Status last verified
- Dec 2020
- First submitted
- 27 Jul 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between McGRATH and Macintosh Laryngoscopy in Laryngeal Mask Airway Insertion
- ClinicalTrials.gov ID
- NCT04509453
- Acronym / sponsor ID
- GRAN-PALM / UNUD-CTR-FK270720-003
- Conditions
- Intubation Complication, Intubation;Difficult, Anesthesia
- Keywords
- successful intubation, classic LMA, video laryngoscopy, difficulty, cuff pressure leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 12 Aug 2020 (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.
Various techniques have been developed to get a good LMA position, one of them is using a laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type. Technological developments have brought laryngoscopes into the video era, one of which is McGRATH's laryngoscope, which from several studies about having an advantage in terms of the first attempt, time, complications, and hemodynamic stability of intubation. It needs to be proven through research on the comparison of clinical outcomes of LMA installation with McGrath laryngoscope and Macintosh laryngoscope.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGRATH | Experimental | Device: McGRATH laryngoscopy, Device: Macintosh laryngoscopy |
| Macintosh | Active comparator | Device: McGRATH laryngoscopy, Device: Macintosh laryngoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients underwent surgery with general anesthesia by LMA insertion in Sanglah General Hospital
- Agreed to be included in the study by signing informed consent
- American Society of Anesthesiologist physical status 1-2
Key exclusion criteria (4 listed)
- Patients unfit for LMA insertion
- Patients with suspected airway management difficulty
- Pregnancy
- Morbid obese
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 laryngoscopyAlso: Group GPatients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy | Device | Macintosh, McGRATH |
| Macintosh laryngoscopyAlso: Group IPatients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy | Device | Macintosh, McGRATH |
Primary outcome
Number of participants with first-attempt success
Time frame: immediately after LMA insertion
Successful LMA insertion within first attempt
Mean arterial pressure
Time frame: immediately after LMA insertion
Mean arterial pressure measured by non-invasive blood pressure monitor
Heart rate
Time frame: immediately after LMA insertion
Heart rate measured by standard monitor
2 secondary outcomes
Time required
Time frame: immediately after LMA insertion
Complications
Time frame: An hour after the the end of surgery
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 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
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 laryngoscopy and Macintosh laryngoscopy in people with Intubation Complication and Intubation;Difficult, run by Udayana University at 1 site in Indonesia.
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 3 inclusion and 4 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 2020. 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 Indonesia. 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?
Number of participants with first-attempt success (time frame: immediately after LMA insertion). 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 2020.