Tracheal Intubation MorbidityNCT01352299
Glottic Visualization & Ease of Intubation With Different Laryngoscope Blades
A study testing Macintosh Laryngoscope blade, MacCoy and Miller in people with Tracheal Intubation Morbidity, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Orotracheal intubation the commonest method used to secure and maintain airway during anaesthesia. A variety of methods are available for orotracheal intubation such as digital or tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA (which is becoming increasing popular, particularly in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tracheal Intubation Morbidity
- What is being tested?
- Macintosh Laryngoscope blade, MacCoy and Miller
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2008to Oct 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the age group of 18-70 yrs
- Patients with ASA grade I and II
- Undergoing surgery under general anaesthesia requiring endotracheal intubation.
Who cannot join
- Patient's refusal for consent for study.
- Patients less than 18 years and more than 70years of age.
- Pregnant patients
- Patients with difficult mask ventilation and /or anticipated difficult intubation
- Patients with pathology in neck, upper respiratory tract and upper alimentary tract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Visualisation of Laryngeal Inlet and Ease of Intubation With Different Laryngoscope Blades.
Orotracheal intubation the commonest method used to secure and maintain airway during anaesthesia. A variety of methods are available for orotracheal intubation such as digital or tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA (which is becoming increasing popular, particularly in cased of anticipated difficult intubation), fibreoptic endoscopic orotracheal intubation (also used when a difficulty is predicted), and conventional and most common method, direct laryngoscopy. Orotracheal intubation is most commonly achieved after visualization of laryngeal inlet with direct laryngoscopy following induction of general anaesthesia and muscle relaxation achieved by administration of a muscle relaxant.
Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane grading, the percentage of glottic opening (POGO Score)Literature suggests that straight blade gives better glottic visualization while tracheal intubation is easier with the curved blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of intubation.
Read the detailed description
This prospective observational study was conducted after obtaining approval from the Institutional Review board of our institute. One hundred and twenty adult patients were included who had given written informed consent. These patients were ASA I or II, between 18-70 yrs of age, were undergoing elective oncosurgery procedure under general anaesthesia requiring endotracheal intubation. Patinets were excluded if they refused consent, were pregnant, had potential difficult mask ventilation and /or anticipated difficult intubation or had pathology in neck, upper respiratory tract and upper alimentary tract. A detailed routine pre-anaesthetic check-up was performed and routine laboratory investigations were done. The patients were randomly divided in four groups of 30 each per laryngoscope blade. Group 1: Macintosh Group Group 2: McCoy's Group Group 3 Miller Group and Group 4: TrueView Group. : included 30 patients.
In the operating room, patients' medical history was again confirmed in brief before subjecting the patient to anaesthesia. Demographic data such as age, sex and weight of the patient was noted. Pulse oximeter, electrocardiograph, capnography and automated non-invasive blood pressure were used for monitoring. Airway assessment was done clinically using Samsung and Young's modification of the Mallampati classification for oropharyngeal view. The patient was asked to assume sitting position, open the mouth maximally, and protrude the tongue but not to phonate. Visibility of the oral and pharyngeal structures was then classified by an observer sitting at the same level as the patient.
Class I: Soft palate,fauces,uvula,pillars visible Class II: Soft palate,fauces,portion of uvula visible Class III: Soft palate,base of uvula visible Class IV : Only hard palate visible A Doughnut-shaped pillow and hard sponge square pillow, totalling about 7 cm in height, was placed under the head of the patient. The patient was preoxygenated with 100% oxygen for three minutes. Anaesthesia was then induced with 1-3 mg/kg of Propofol or thiopentone sodium 5 mg/kg, fentanyl 2 µg/kg. Feasibility of ventilation with a face mask was checked prior to injection of non-depolarising muscle relaxant. After ventilation was confirmed a vecuronium was administered and the patient was ventilated with isoflurane 0.5-1% in a 50:50 mixture of O2 and N2O for 3 minutes then ventilated for 1 minute with 100% O2. Then laryngoscopy and tracheal intubation accomplished with the selected laryngoscope blade. The laryngoscopy and intubation were carried out by a single anaesthesiologist who had trained with all laryngoscope blades till he had obtained sufficient familiarity all four laryngoscope blades. We studied following aspects during tracheal intubation.
Visualization of laryngeal inlet: This was graded using Cormack Lehane Grades:
Grade 1: complete glottis visible Grade 2: anterior glottis not seen Grade 3: epiglottis seen but not glottis Grade 4: epiglottis not seen
Ease of intubation: This was graded as follows:
Grade 1: Intubation easy Grade 2: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space Grade 3: Intubation requiring multiple attempts and a curved stylet Grade 4: Failure to intubate with the assigned laryngoscope Number of attempts: We noted the number of attempts needed for intubation with that particular blade in each patient.
Requirement of external laryngeal manipulation: Classified as Grade 1: No requirement of external laryngeal manipulations and Grade 2: Requirement of external laryngeal manipulation.
Statistical analysis: Demographic data, Mallampatti Classification and other variables were compared using the Chi Square test. A p value of > 0.05 was taken to assume statistical significance.
- Conditions
- Tracheal Intubation Morbidity
- Being tested
- Macintosh Laryngoscope blade, MacCoy, Miller, TrueView
- Keywords
- Macintosh laryngoscope blade, MacCoy laryngoscope blade, Miller laryngoscope blade, TrueView laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh Laryngoscope bladeDevice
Also called Conventional Curved laryngoscope blade
Laryngoscopy performed with Macintosh Laryngoscope
MacCoyDevice
Also called Curved laryngoscope blade with a hinged tip
Laryngoscopy performed with MacCoy Laryngoscope
MillerDevice
Also called Conventional Straight laryngoscope blade
Laryngoscopy performed with Miller Laryngoscope
TrueViewDevice
Also called Straight blade with prism
Laryngoscopy performed with TrueView laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Macintosh | Active comparator | Laryngoscopy performed with Macintosh Laryngoscope Receives: Device: Macintosh Laryngoscope blade |
| McCoy | Active comparator | Laryngoscopy performed with MacCoy Laryngoscope Receives: Device: MacCoy |
| Miller | Active comparator | Laryngoscopy performed with Miller Laryngoscope Receives: Device: Miller |
| TrueView | Active comparator | Laryngoscopy performed with TrueView Laryngoscope Receives: Device: TrueView |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of glottis and Ease of Intubation
Visualization of laryngeal inlet:
Grade 1: complete glottis visible Grade 2: anterior glottis not seen Grade 3: epiglottis seen but not glottis Grade 4: epiglottis not seen
Ease of intubation:
Grade 1: Intubation easy Grade 2: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space Grade 3: Intubation requiring multiple attempts and a curved stylet Grade 4: Failure to intubate with the assigned laryngoscope
Measured: During Laryngoscopy and intubation average time 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Intubation MorbidityStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Atul P Kulkarni, MD Anaes, Principal investigator, Professor Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352299
- Sponsor's protocol ID
- Akulkarni2
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visualisation of Laryngeal Inlet and Ease of Intubation With Different Laryngoscope Blades.
- ClinicalTrials.gov ID
- NCT01352299
- Acronym / sponsor ID
- Akulkarni2
- Conditions
- Tracheal Intubation Morbidity
- Keywords
- Macintosh laryngoscope blade, MacCoy laryngoscope blade, Miller laryngoscope blade, TrueView laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 May 2011 (estimated)
- 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.
Orotracheal intubation the commonest method used to secure and maintain airway during anaesthesia. A variety of methods are available for orotracheal intubation such as digital or tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA (which is becoming increasing popular, particularly in cased of anticipated difficult intubation), fibreoptic endoscopic orotracheal intubation (also used when a difficulty is predicted), and conventional and most common method, direct laryngoscopy. Orotracheal intubation is most commonly achieved after visualization of laryngeal inlet with direct laryngoscopy following induction of general anaesthesia and muscle relaxation achieved by administration of a muscle relaxant.
Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane grading, the percentage of glottic opening (POGO Score)Literature suggests that straight blade gives better glottic visualization while tracheal intubation is easier with the curved blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of intubation.
Detailed description
This prospective observational study was conducted after obtaining approval from the Institutional Review board of our institute. One hundred and twenty adult patients were included who had given written informed consent. These patients were ASA I or II, between 18-70 yrs of age, were undergoing elective oncosurgery procedure under general anaesthesia requiring endotracheal intubation. Patinets were excluded if they refused consent, were pregnant, had potential difficult mask ventilation and /or anticipated difficult intubation or had pathology in neck, upper respiratory tract and upper alimentary tract. A detailed routine pre-anaesthetic check-up was performed and routine laboratory investigations were done. The patients were randomly divided in four groups of 30 each per laryngoscope blade. Group 1: Macintosh Group Group 2: McCoy's Group Group 3 Miller Group and Group 4: TrueView Group. : included 30 patients.
In the operating room, patients' medical history was again confirmed in brief before subjecting the patient to anaesthesia. Demographic data such as age, sex and weight of the patient was noted. Pulse oximeter, electrocardiograph, capnography and automated non-invasive blood pressure were used for monitoring. Airway assessment was done clinically using Samsung and Young's modification of the Mallampati classification for oropharyngeal view. The patient was asked to assume sitting position, open the mouth maximally, and protrude the tongue but not to phonate. Visibility of the oral and pharyngeal structures was then classified by an observer sitting at the same level as the patient.
Class I: Soft palate,fauces,uvula,pillars visible Class II: Soft palate,fauces,portion of uvula visible Class III: Soft palate,base of uvula visible Class IV : Only hard palate visible A Doughnut-shaped pillow and hard sponge square pillow, totalling about 7 cm in height, was placed under the head of the patient. The patient was preoxygenated with 100% oxygen for three minutes. Anaesthesia was then induced with 1-3 mg/kg of Propofol or thiopentone sodium 5 mg/kg, fentanyl 2 µg/kg. Feasibility of ventilation with a face mask was checked prior to injection of non-depolarising muscle relaxant. After ventilation was confirmed a vecuronium was administered and the patient was ventilated with isoflurane 0.5-1% in a 50:50 mixture of O2 and N2O for 3 minutes then ventilated for 1 minute with 100% O2. Then laryngoscopy and tracheal intubation accomplished with the selected laryngoscope blade. The laryngoscopy and intubation were carried out by a single anaesthesiologist who had trained with all laryngoscope blades till he had obtained sufficient familiarity all four laryngoscope blades. We studied following aspects during tracheal intubation.
Visualization of laryngeal inlet: This was graded using Cormack Lehane Grades:
Grade 1: complete glottis visible Grade 2: anterior glottis not seen Grade 3: epiglottis seen but not glottis Grade 4: epiglottis not seen
Ease of intubation: This was graded as follows:
Grade 1: Intubation easy Grade 2: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space Grade 3: Intubation requiring multiple attempts and a curved stylet Grade 4: Failure to intubate with the assigned laryngoscope Number of attempts: We noted the number of attempts needed for intubation with that particular blade in each patient.
Requirement of external laryngeal manipulation: Classified as Grade 1: No requirement of external laryngeal manipulations and Grade 2: Requirement of external laryngeal manipulation.
Statistical analysis: Demographic data, Mallampatti Classification and other variables were compared using the Chi Square test. A p value of > 0.05 was taken to assume statistical significance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macintosh | Active comparator | Device: Macintosh Laryngoscope bladeLaryngoscopy performed with Macintosh Laryngoscope |
| McCoy | Active comparator | Device: MacCoyLaryngoscopy performed with MacCoy Laryngoscope |
| Miller | Active comparator | Device: MillerLaryngoscopy performed with Miller Laryngoscope |
| TrueView | Active comparator | Device: TrueViewLaryngoscopy performed with TrueView Laryngoscope |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in the age group of 18-70 yrs
- Patients with ASA grade I and II
- Undergoing surgery under general anaesthesia requiring endotracheal intubation.
Key exclusion criteria (5 listed)
- Patient's refusal for consent for study.
- Patients less than 18 years and more than 70years of age.
- Pregnant patients
- Patients with difficult mask ventilation and /or anticipated difficult intubation
- Patients with pathology in neck, upper respiratory tract and upper alimentary tract.
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 Laryngoscope bladeAlso: Conventional Curved laryngoscope bladeLaryngoscopy performed with Macintosh Laryngoscope | Device | Macintosh |
| MacCoyAlso: Curved laryngoscope blade with a hinged tipLaryngoscopy performed with MacCoy Laryngoscope | Device | McCoy |
| MillerAlso: Conventional Straight laryngoscope bladeLaryngoscopy performed with Miller Laryngoscope | Device | Miller |
| TrueViewAlso: Straight blade with prismLaryngoscopy performed with TrueView laryngoscope | Device | TrueView |
Primary outcome
Visualization of glottis and Ease of Intubation
Time frame: During Laryngoscopy and intubation average time 1 minute
Visualization of laryngeal inlet: Grade 1: complete glottis visible Grade 2: anterior glottis not seen Grade 3: epiglottis seen but not glottis Grade 4: epiglottis not seen Ease of intubation: Grade 1: Intubation easy Grade 2: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space Grade 3: Intubation requiring multiple attempts and a curved stylet Grade 4: Failure to intubate with the assigned laryngoscope
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 11 May 2011.
Related trials for Tracheal Intubation Morbidity
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
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Not yet recruitingPhase 2/3
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
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.
Atul P Kulkarni, MD Anaes principal investigator
Professor Tata Memorial Hospital
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 Laryngoscope blade, MacCoy and Miller in people with Tracheal Intubation Morbidity, run by Tata Memorial Hospital at 1 site in India.
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 11 May 2011. 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 India. 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?
Visualization of glottis and Ease of Intubation (time frame: During Laryngoscopy and intubation average time 1 minute). 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 May 2011.