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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

India1 site
  • Tata Memorial Hopsital

    Mumbai, Maharashtra, 400012

Other trials in India

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.

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 groups in NCT01352299
Study groupRoleWhat they receive
MacintoshActive comparatorLaryngoscopy performed with Macintosh Laryngoscope
Receives: Device: Macintosh Laryngoscope blade
McCoyActive comparatorLaryngoscopy performed with MacCoy Laryngoscope
Receives: Device: MacCoy
MillerActive comparatorLaryngoscopy performed with Miller Laryngoscope
Receives: Device: Miller
TrueViewActive comparatorLaryngoscopy performed with TrueView Laryngoscope
Receives: Device: TrueView

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted11 May 2011 (estimated)
  2. Study startAug 2008
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

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)
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

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.

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