Intubation; DifficultNCT02664532
Miller Straight Blade vs Macintosh Blade
A study testing Miller group and Macintosh group in people with Intubation; Difficult, run by Tata Main Hospital.
Trial summary
The purpose of this prospective open labeled randomized study was to compare the "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in routine intubations in non-difficult airways. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Miller group and Macintosh group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All ASA I \& II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation
Who cannot join
- Patients with anticipated difficult airway
- Cervical spine disorders
- Anesthesia requiring rapid sequence induction
About this study
Official title: Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation
The purpose of this prospective open labeled randomized study was to compare the "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in routine intubations in non-difficult airways.
Read the detailed description
One hundred and fifty patients with predicted non difficult airway were randomly assigned into two groups. After induction of anaesthesia laryngoscopy was performed with respective blades and trachea intubated. Parameters monitored were: glottis view obtained during laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration of laryngoscopy in seconds and encountered complications.
- Conditions
- Intubation; Difficult
- Being tested
- Miller group, Macintosh group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller groupOther
Miller blade was used for laryngoscopy
Macintosh groupOther
Macintosh blade was used for laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Miller group | Experimental | In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan. Receives: Other: Miller group |
| Macintosh group | Other | In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan. Receives: Other: Macintosh group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Intubation or Degree of Difficulty With Intubation
Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope
Measured: 60 seconds
Secondary outcomes (3)
Cormack Lehane Grading
Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible
Measured: 60 seconds
Number of Intubation Attempts
An intubation attempt is defined as "intubation activities occurring during a single continuous laryngoscopy maneuver". Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt.
Measured: 180 seconds
Total Laryngoscopy Duration in Seconds
The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation.
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Main Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Deb Sanjay Nag, Tata Main Hospital
- Investigators
- Bhanu Pratap Swain, DNB, Principal investigator, Tata Main Hospital, Jamshedpur,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664532
- Sponsor's protocol ID
- PR/JHTMH/09242A
- Status last verified
- Feb 2016
- First submitted
- 10 Jan 2016
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation
- ClinicalTrials.gov ID
- NCT02664532
- Acronym / sponsor ID
- PR/JHTMH/09242A
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tata Main HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 11 Mar 2016
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 this prospective open labeled randomized study was to compare the "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in routine intubations in non-difficult airways.
Detailed description
One hundred and fifty patients with predicted non difficult airway were randomly assigned into two groups. After induction of anaesthesia laryngoscopy was performed with respective blades and trachea intubated. Parameters monitored were: glottis view obtained during laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration of laryngoscopy in seconds and encountered complications.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miller group | Experimental | Other: Miller groupIn Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan. |
| Macintosh group | Other | Other: Macintosh groupIn Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All ASA I \& II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation
Key exclusion criteria (3 listed)
- Patients with anticipated difficult airway
- Cervical spine disorders
- Anesthesia requiring rapid sequence induction
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 |
|---|---|---|
| Miller groupMiller blade was used for laryngoscopy | Other | Miller group |
| Macintosh groupMacintosh blade was used for laryngoscopy | Other | Macintosh group |
Primary outcome
Ease of Intubation or Degree of Difficulty With Intubation
Time frame: 60 seconds
Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope
3 secondary outcomes
Cormack Lehane Grading
Time frame: 60 seconds
Number of Intubation Attempts
Time frame: 180 seconds
Total Laryngoscopy Duration in Seconds
Time frame: 180 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Bhanu Pratap Swain, DNB principal investigator
Tata Main Hospital, Jamshedpur,India
Questions about this trial
What is this clinical trial studying?
A study testing Miller group and Macintosh group in people with Intubation; Difficult, run by Tata Main Hospital.
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 1 inclusion and 3 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 11 Mar 2016). 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 or Degree of Difficulty With Intubation (time frame: 60 seconds). 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 11 Mar 2016.