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CTRI Number  CTRI/2018/02/011806 [Registered on: 09/02/2018] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Visualisation to put in tube for General Anesthesia using three different equipments 
Scientific Title of Study   Efficacy of Cormack Lehane grading for intubation difficulty with three different videolaryngoscopes in comparison with macintosh laryngoscope: A Prospective randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavitha 
Designation  Associate professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Anesthesiology Nizams Institute of Medical Sciences Punjagutta Hyderabad

Hyderabad
ANDHRA PRADESH
500080
India 
Phone    
Fax    
Email  drkarunya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavitha 
Designation  Associate professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Anesthesiology Nizams Institute of Medical Sciences Punjagutta Hyderabad

Hyderabad
ANDHRA PRADESH
500080
India 
Phone    
Fax    
Email  drkarunya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavitha 
Designation  Associate professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Anesthesiology Nizams Institute of Medical Sciences Punjagutta Hyderabad

Hyderabad
ANDHRA PRADESH
500080
India 
Phone    
Fax    
Email  drkarunya@gmail.com  
 
Source of Monetary or Material Support  
Institution 
 
Primary Sponsor  
Name  NIMS 
Address  Nizams Institute of Medical Sciences Punjagutta Hyderabad 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavitha  Nizams Institute of Medical Sciences  Dept of Anesthesia Nizams Institute of medical Sciences Punjagutta Hyderabad
Hyderabad
ANDHRA PRADESH 
8143769301

drkarunya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, Patients undergoing surgery under general anesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airtraq  Type of Videolaryngoscope 
Intervention  C MAC  Another type of non channelled videolaryngoscope 
Intervention  MacGrath  Type of non channelled videolaryngoscope 
Comparator Agent  Macintosh  LAryngoscope used normally for intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA Physical status – I, II and III
Age: 18- 70
Elective surgery
General Anesthesia
 
 
ExclusionCriteria 
Details  Pediatric cases
Emergency
Anticipated rapid desaturation
Mouth opening less than 3 cm
Procedures under spontaneous ventilation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate the use of cormack lehane grading and intubation difficulty scores for assessment of intubation difficulty in three different videolaryngoscopes in comparison with direct laryngoscope.  At the time of intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Ease of intubation
Time taken for intubation 
At the time of intubation  
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
Final Enrollment numbers achieved (Total)= "360"
Final Enrollment numbers achieved (India)="360" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/11/2018 
Date of Study Completion (India) 13/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Efficacy of Cormack Lehane grading for intubation difficulty with three different videolaryngoscopes in comparison with macintosh laryngoscope: A Prospective randomised controlled trial

Introduction

Difficult and failed intubations are the leading cause of anesthesia related morbidity and mortality among all others1. There are many strategies developed to assess and manage difficult intubations but still many difficul tintubation scenarios are encountered only at induction. Multiple types of indirect laryngoscopes have come into vogue and they play a major role in difficult airway algorithm2, 3.

Videolaryngoscope is an indirect laryngoscope that shows non-line sight view of the larynx. All have an intense light source and fibreoptic camera built in a laryngoscope blade. Direct laryngoscopy requires alignment of oral, pharyngeal and laryngeal axis whereas indirect videolaryngoscopes require only pharyngeal and laryngeal axis to be aligned for view of glottis.

Several studies have shown that videolaryngoscopes improve the visualisation of glottic aperture in terms of better Cormack lehane4 grade. While one gets a better view with these equipments there is sometimes problem associated with negotiation of endotracheal tube. This is because there is no line of sight and therefore no space through which to pass the ETT. This problem is multitude in VDLs without guiding channel as it is difficult to visualise the ETT within the minimal field of vision available. Using malleable stylet to angle the ETT to the curvature of laryngoscopic blade helps in nonchanneled VDLs. Channeled VDLs are primarily dependent of manuevering the scope to appropriately negotiate the ETT into the glottis.

Extrapolating cormack lehane5 classification to VDLs is not applicable as glottic visualisation may not always equate to successful intubation in them. Insertion and advancement of ETT may fail despite clear video assisted visualisation. Furthermore intubation using VDLs tend to be slower due to lack of experience, difficulty with tube advancement and division of operators attention in two domains.

Intubation difficulty scores (IDSs) are typically used to indicate the difficulties of intubations with different laryngoscopes6, 7, 8 , although it remains controversial whether the IDS is suitable for the evaluation of indirect laryngoscopes9 . The optimisation manuevers to be applied for different  indirect laryngoscopes are different and hence cannot be utilised in common.

This study was therefore designed to evaluate the use of cormack lehane grading and intubation difficulty scores for assessment of intubation difficulty in three different videolaryngoscopes in comparison with direct laryngoscope.

Hypothesis: Cormack lehane grading is different with different videolaryngoscopes and is not efficient to assess the difficulty in intubation with videolaryngoscopes

The C-MAC (Karl Storz Endoscopy, Tuttlingen, Germany) is an indirect VDL that comprises of standard Macintosh blade attached to a video unit. A potential advantage of this non channelled scope is that it can be used both as direct as wellas indirect laryngoscope. The profiency of the device is also easy to acquire than other VDLs because of its usual scope design.

Airtraq (Prodol Meditec SA, Vizcaya, Spain) consists of series of lenses and an exaggerated curvature and provides high quality wide angle view of the larynx without alignment of any axis. It has a side channel for placement of endotracheal tube to facilitate an easier and faster intubation. Though it is channeled there is still possibility of passing ETT which require correcting manuevers like excess lifting or rotational movement. Despite these issues airtraq has been proven successful in multiple situations of difficult airway.

MacGrath (Aircraft Medical, Edinburgh, UK) is fully portable VDL which has disposable blade fitted over a steelcamera support with an LCD screen fitted on the top of the handle. Thelength of the blade can be adjusted to suit the patient size and use of stylet is recommended for intubations.

 

Methodology:

Study design: Prospective, Randomised, controlled Single centered Cross sectional study

Study Location: Nizam’s Institute of Medical Sciences, Hyderabad. Tertiary care hospital deemed University.

Study population: (Sample size) A total of 360 patients (with 90 in each group) will be enrolled.There are no studies comparing cormack lehane grading with videolaryngoscopes. A priori analysis had indicated a sample size of 90 patients in each group to provide 90% power and a 5% level of significance with effect size of 0.2.

Study Groups: Group A- Airtraq

                        Group C – C- MAC

                        Group MG – McGrath

                        Group M – MacIntosh

Study Criteria:

            Inclusion: ASA Physical status – I, II and III

                        Age: 18- 70

                        Elective surgery

                        General Anesthesia

            Exclusion: Pregnancy

                        Pediatric cases

                        Emergency

                        Anticipated rapid desaturation

                        Mouth opening less than 3 cm

Procedures under spontaneous ventilation

Study Procedure:

After obtaining institutional ethics committee approval patients will be recruited for the study and informed consent will be obtained. Preoperative assessment and premedication will be based on the institutional protocol. On the day of surgery, patients will be connected to monitors like eelctrocardiogram, pulse oximetry and non invasive blood pressure monitors. An intravenous cannula will be secured and connected to fluid. Patients will be premedicated and induced as per the wish of the intubating anesthesiologist. Mask ventilation will be checked and graded accordingly before muscle relaxant. At the end of three minutes, the assigned laryngoscope as per randomisation is inserted in the oral cavity. The Cormack lehane grading is announced by the intubator followed by intubation. Closed circuit will be connectedto the endotracheal tube and the tube postionwillbe confirmed by end tidal carbondioxide trace and auscultation. Anesthesia is maintained as per the institutional protocol in the intraoperative period.

Parameters studied:

Airway parameters: Mouth opening

            Mentohyoid distance

            Thyromental distance

            Sternomental distance

            Neck circumference

            Neck movements

            Intraoral pathologies

            Pathologies in neck

Airway management:

            Mask ventilation grading: grade 1-Ventilated by mask

                        Grade 2- Ventilated by mask with oralairway / adjuvant

                        Grade 3- Difficult ( Inadequate/unstable/ Requiring 2 people)

                        Grade 4- Unable to mask ventilate

            Type of equipment used for intubation

            Time taken for Laryngoscopy- Time frominsertion of blade between teeth until the anesthesiologist had obtained the best possible view of the glottis

            Time taken for intubation- Time from best visualisation of glottis to ETT placement through the vocal cords as evidenced by visual confirmation.

            Cormack Lehane grade-

            Intubation Difficulty Score –

            Use of Stillet/ Bouggie-

            Total number of passes of the ETT in the direction of cords

            Position of glottis where the ETT hitches whenit is unable to pass the ETT

            Any change in the scope used,If so why?

Intubation Grading: depending on the manuevers used which are Laryngeal pressure, Bouggie / Stillet, Changes in head or scope position to bring glottic aperture to the centre of the field.

            Grade 1- No manuevers

            Grade 2- 1 manuever

            Grade 3- 2 Manuevers

            Grade 4- 3 Manuevers

Complications:

            Desaturation to less than 90%

            Trauma / Bleeding in the airway

Esophageal intubation

Failed attempt- a) If anesthesiologist felt it clinically appropriate to abandon test laryngoscope and use an alternative device

            b) Trachea was not intubated in three attempts with selected laryngoscope

 

The ease of intubation was measured by asking every student to evaluate the ease of his intubation attempt for each device using a linear scale (0 = easy, 10 = difficult).

Statistical analysis:

The data will be recorded and statistically analysed using SPSS software version 17.

 

References:

1. Cheney FW. The American Society of Anesthesiologists Closed Claims Project: what have we learned, how has it affected practice, and how will it affect practice in the future? Anesthesiology 1999; 91: 552–6.

2. Tse JC, Rimm EB, Hussain A. Predicting difficult endotracheal intubation in surgical patients scheduled for general anesthesia: a prospective blind study. Anesthesia & analgesia 1995; 81: 254–8.

3. American Society of Anesthesiologists: Practice guidelines for management of the difficult airway: An updated report. Anesthesiology 2003; 98:1269–1277.

4. Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia.  1984;39:1105–11

5. Dharshi K, Jai D, Justin M, Louise E,Jon G Graham, Laurence Weinberg.A review on video laryngoscopes relevant to intensive care unit. Indian J of Critical care Medicine 2014: 18(7); 442-52.

6. Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997;87:1290–7.

7. Benumof JL. Intubation difficulty scale: anticipated best use. Anesthesiology. 1997;87:1273–4.

8. Puchner W, Drabauer L, Kern K, Mayer C, Bierbaumer J, Rehak PH. Indirect versus direct laryngoscopy for routine nasotracheal intubation. J Clin Anesth. 2011;23:280–5.

9. Combes X, Dhonneur G. Difficult tracheal intubation. Br J Anaesth. 2010;104:260–1.

 
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