Intubation;DifficultNCT04566224
Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial
A study testing Macintosh size 2 blade and Macintosh size 3 blade in people with Intubation;Difficult, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Macintosh size 2 blade and Macintosh size 3 blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2011to 31 May 2012
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
- undergo elective surgery
- receive endotracheal intubation
Who cannot join
- with known difficult airway (i.e. pathology of the neck, upper airway or alimentary tracts)
- with risks of pulmonary aspiration (i.e. emergent operation, pregnancy or inadequate nil per os)
- with previous difficult intubation history
- intubation attempts more than three times
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition.
Read the detailed description
Selection the most appropriate size of laryngoscope blade size could not only increased intubation successful rate at the first time but also decrease the incidence of tissue trauma. Laryngoscope blade used in daily practice is usually Macintosh 3. However, compared with Caucasian people, Asian people are smaller and thinner especially in women. This study aims to confirm that the Macintosh 2 blade is not inferior to size 3 blade in laryngeal view and intubation rate.
Female patients without known difficult airway will be enrolled and allocated into Macintosh blade size 2 and size 3 groups. The age, body weight, body height, Mallampati classification, mouth opening, thyromental distance, neck circumference, intubation time, Cormack-Lehane grade, intubation difficulty scale scores and associated teeth or tissue traumas will be recorded.
- Conditions
- Intubation;Difficult
- Being tested
- Macintosh size 2 blade, Macintosh size 3 blade
- Keywords
- Intubation rate, Macintosh blade, Asian women, intubation difficulty scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh size 2 bladeDevice
intubate with Macintosh size 2 blade
Macintosh size 3 bladeDevice
intubate with Macintosh size 3 blade
| Study group | Role | What they receive |
|---|---|---|
| Macintosh 2 group | Experimental | Using Macintosh size 2 blade for direct laryngoscope intubation according to randomization Receives: Device: Macintosh size 2 blade |
| Macintosh 3 group | Active comparator | Using Macintosh size 3 blade for direct laryngoscope intubation according to randomization Receives: Device: Macintosh size 3 blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time from laryngoscope insertion to the first adequate lung insufflation
Measured: 0-10 minutes during induction
Cormack-Lehane grade
Classification of glottis view during intubation
Measured: 0-10 minutes during induction
Intubation difficulty scale scores
Scoring system to assess the difficulty of intubation in each patient
Measured: 0-10 minutes during induction
Tissue trauma
Any tissue trauma event related to intubation
Measured: 0-10 minutes during induction
Teeth trauma
Any dental damage event related to intubation
Measured: 0-10 minutes during induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Jun 2011
- Primary completion31 May 2012
- Study completion31 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying-Chun Lin, Mackay Memorial Hospital
- Investigators
- Nuan-Yen Su, MS, Study director, Mackay Memorial hospital, department of anesthesiology, attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566224
- Sponsor's protocol ID
- 11MMHIS107
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mellick LB, Edholm T, Corbett SW. Pediatric laryngoscope blade size selection using facial landmarks. Pediatr Emerg Care. 2006 Apr;22(4):226-9. doi: 10.1097/01.pec.0000210171.17892.7a.
PubMed 16651910Ashfaque M, Mason J, Al-Shaikh B, Adegoke K. A comparison of the Laryngopharyngeal Examination blade and the English Macintosh laryngoscope blade using an intubating manikin: a prospective randomized crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):917-22. doi: 10.1097/EJA.0b013e32832c7848.
PubMed 19593148Asai T, Matsumoto S, Fujise K, Johmura S, Shingu K. Comparison of two Macintosh laryngoscope blades in 300 patients. Br J Anaesth. 2003 Apr;90(4):457-60. doi: 10.1093/bja/aeg086.
PubMed 12644417Watanabe S, Suga A, Asakura N, Takeshima R, Kimura T, Taguchi N, Kumagai M. Determination of the distance between the laryngoscope blade and the upper incisors during direct laryngoscopy: comparisons of a curved, an angulated straight, and two straight blades. Anesth Analg. 1994 Oct;79(4):638-41. doi: 10.1213/00000539-199410000-00004.
PubMed 7943768
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04566224
- Acronym / sponsor ID
- 11MMHIS107
- Conditions
- Intubation;Difficult
- Keywords
- Intubation rate, Macintosh blade, Asian women, intubation difficulty scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 31 May 2012 (actual)
- Study completion
- 31 May 2012 (actual)
- First posted
- 28 Sep 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.
Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition.
Detailed description
Selection the most appropriate size of laryngoscope blade size could not only increased intubation successful rate at the first time but also decrease the incidence of tissue trauma. Laryngoscope blade used in daily practice is usually Macintosh 3. However, compared with Caucasian people, Asian people are smaller and thinner especially in women. This study aims to confirm that the Macintosh 2 blade is not inferior to size 3 blade in laryngeal view and intubation rate.
Female patients without known difficult airway will be enrolled and allocated into Macintosh blade size 2 and size 3 groups. The age, body weight, body height, Mallampati classification, mouth opening, thyromental distance, neck circumference, intubation time, Cormack-Lehane grade, intubation difficulty scale scores and associated teeth or tissue traumas will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh 2 group | Experimental | Device: Macintosh size 2 bladeUsing Macintosh size 2 blade for direct laryngoscope intubation according to randomization |
| Macintosh 3 group | Active comparator | Device: Macintosh size 3 bladeUsing Macintosh size 3 blade for direct laryngoscope intubation according to randomization |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
- undergo elective surgery
- receive endotracheal intubation
Key exclusion criteria (5 listed)
- with known difficult airway (i.e. pathology of the neck, upper airway or alimentary tracts)
- with risks of pulmonary aspiration (i.e. emergent operation, pregnancy or inadequate nil per os)
- with previous difficult intubation history
- intubation attempts more than three times
- patient refusal
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 |
|---|---|---|
| Macintosh size 2 bladeintubate with Macintosh size 2 blade | Device | Macintosh 2 group |
| Macintosh size 3 bladeintubate with Macintosh size 3 blade | Device | Macintosh 3 group |
Primary outcome
Intubation time
Time frame: 0-10 minutes during induction
Time from laryngoscope insertion to the first adequate lung insufflation
Cormack-Lehane grade
Time frame: 0-10 minutes during induction
Classification of glottis view during intubation
Intubation difficulty scale scores
Time frame: 0-10 minutes during induction
Scoring system to assess the difficulty of intubation in each patient
Tissue trauma
Time frame: 0-10 minutes during induction
Any tissue trauma event related to intubation
Teeth trauma
Time frame: 0-10 minutes during induction
Any dental damage event related to intubation
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 28 Sep 2020.
- Background: PubMed 16651910Mellick LB, Edholm T, Corbett SW. Pediatric laryngoscope blade size selection using facial landmarks. Pediatr Emerg Care. 2006 Apr;22(4):226-9. doi: 10.1097/01.pec.0000210171.17892.7a.
- Background: PubMed 19593148Ashfaque M, Mason J, Al-Shaikh B, Adegoke K. A comparison of the Laryngopharyngeal Examination blade and the English Macintosh laryngoscope blade using an intubating manikin: a prospective randomized crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):917-22. doi: 10.1097/EJA.0b013e32832c7848.
- Background: PubMed 12644417Asai T, Matsumoto S, Fujise K, Johmura S, Shingu K. Comparison of two Macintosh laryngoscope blades in 300 patients. Br J Anaesth. 2003 Apr;90(4):457-60. doi: 10.1093/bja/aeg086.
- Background: PubMed 7943768Watanabe S, Suga A, Asakura N, Takeshima R, Kimura T, Taguchi N, Kumagai M. Determination of the distance between the laryngoscope blade and the upper incisors during direct laryngoscopy: comparisons of a curved, an angulated straight, and two straight blades. Anesth Analg. 1994 Oct;79(4):638-41. doi: 10.1213/00000539-199410000-00004.
- Individual participant dataSharing planned: No
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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.
Nuan-Yen Su, MS study director
Mackay Memorial hospital, department of anesthesiology, attending physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh size 2 blade and Macintosh size 3 blade in people with Intubation;Difficult, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 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 28 Sep 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 Taiwan. 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?
Intubation time (time frame: 0-10 minutes during induction). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566224, which also lists 4 linked publications.
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 28 Sep 2020.