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CTRI Number  CTRI/2015/06/005915 [Registered on: 15/06/2015] Trial Registered Prospectively
Last Modified On: 04/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Videolaryngoscopes with conventional laryngoscope for intubation in cervical spine instability 
Scientific Title of Study   Comparative Evaluation of Performance of GlideScope® and McGrath® Videolaryngoscopes with Conventional Macintosh Laryngoscope for Laryngoscopy and Intubation in patients with immobilized Cervical spine – A randomized 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 Rashmi Salhotra 
Designation  Assistant Professor 
Affiliation  UCMS and GTB Hospital 
Address  A-2/268, II Floor, Paschim Vihar New Delhi
Dilshad Garden Delhi
East
DELHI
110063
India 
Phone  9868399753  
Fax    
Email  rashmichabra@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Salhotra 
Designation  Assistant Professor 
Affiliation  UCMS and GTB Hospital 
Address  A-2/268, II Floor, Paschim Vihar New Delhi
Dilshad Garden Delhi

DELHI
110063
India 
Phone  9868399753  
Fax    
Email  rashmichabra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rashmi Salhotra 
Designation  Assistant Professor 
Affiliation  UCMS and GTB Hospital 
Address  A-2/268, II Floor, Paschim Vihar New Delhi
Dilshad Garden Delhi

DELHI
110063
India 
Phone  9868399753  
Fax    
Email  rashmichabra@yahoo.com  
 
Source of Monetary or Material Support  
Dr. Rashmi Salhotra Department of Anaesthesiology and Critical Care UCMS and Guru Teg Bahadur Hospital Dilshad Garden Delhi 
 
Primary Sponsor  
Name  GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, UCMS and GTB H Delhi 
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 Rashmi Salhotra  Operation Theatres of GTB Hospital  Dilshad Garden Delhi
East
DELHI 
9868399753

rashmichabra@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Academic and Ethical Committee GTB Hospital Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, Either sex About to undergo elective surgical procedures requiring general anaesthesia with tracheal intubation Age between 18-60 years. ASA physical status I-II. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endotracheal Intubation  Endotracheal intubation will be attempted in the study participants after application of neck collar with either of the three laryngoscopes and the success rate of intubation and secondary outcomes will be recorded. Minimum of one attempt and maximum of three attempts will be allowed. If after three attempts, it is not possible to intubate, it will be considered as failure to intubate and then Proseal LMA will be used to maintain the airway. 
Comparator Agent  GlideScope Videolaryngoscope  Videolaryngoscope 
Comparator Agent  MacIntosh Laryngoscope  Intubation will be attempted after induction of anaesthesia. Frequency will be not more than three attempts with the laryngoscope.  
Comparator Agent  McGrath Laryngoscope  Intubation will be attempted after induction of anaesthesia. Frequency will be not more than three attempts with the laryngoscope.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  About to undergo elective surgery under endotracheal general anaesthesia 
 
ExclusionCriteria 
Details  Patients who do not give consent to participate in the trial
Cervical spine disorders
Patients requiring surgeries of oral cavity, larynx, pharynx and neck.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Success rate of intubation in the first attempt  T0: immediately after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Time for successful intubation
Glottic view according to POGO score and C&L grading
Number of intubation attempts
Difficulty in laryngoscopy
Difficulty in intubation
Requirement of release of neck collar
Complications, if any
 
T0: after intubation
T1: before extubation
T2: after extubation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2015 
Date of Study Completion (India) 15/02/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published in World Journal of Research and Review 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Endotracheal intubation is a potentially lifesaving procedure used in various routine clinical and emergency situations like trauma to the airway, head injury, facio-maxillary trauma. These patients are considered to have cervical spine injury until proven otherwise. Special care has to be taken during intubation procedure by immobilizing the cervical spine with a collar or by manual-in-line-stabilization (MILS). Difficulty with laryngoscopy and intubation arising from multiple attempts or excessive movement of neck for alignment of oro-pharyngeal-laryngeal axes may cause serious complications by injuring the vital centers located in the cervical spinal cord.

Various devices to intubate such patients have been used e.g. various supraglottic airways (1), fiberoptic bronchoscope (2), lighted stylets (3), conventional laryngoscopes or videolaryngoscopes (VLS) (4). Videolaryngoscopes have the advantage of containing miniature video cameras that provide indirect glottic view without requiring oral, pharyngeal and laryngeal axes alignment. McGrath® and GlideScope® are two commonly used VLS. McGrath® is fully portable having an LCD display attached to its handle, whereas GlideScope® has a separate viewing screen.

 

Lacunae in the existing knowledge

Extensive search of literature revealed that there are a few case reports or case series mentioning the successful use of McGrath® videolaryngoscope in simulated difficult airway scenarios or cervical spine immobilization (5, 6). GildeScope® has also proven to be useful in severe cervical spondylolisthesis (7). Recently a simulation study in manikins on the comparative evaluation of different VLS, including MVL and GlideScope®  in trapped car accident victims (8) and immobilized cervical spine (9) have been published. However, there are no randomized controlled trials on ease of intubation, time to intubate and success rate of intubation using these VLS in patients with immobilized cervical spine.

Therefore, the present study is designed to evaluate and compare the performance of McGrath® and GlideScope® videolaryngoscopes with the gold standard Macintosh laryngoscope in adults with normal cervical spine undergoing elective surgeries requiring intubation of trachea and whose neck has been immobilized with the help of cervical collar. The primary outcome measure to define performance of the laryngoscope will be success rate of intubation in the first attempt. The secondary outcome measures would be time taken for successful intubation, number of attempts, glottic view according to Percentage of Glottic Opening (POGO) score (10, 11), Cormack and Lehane (C&L) score (12), difficulty in laryngoscopy and difficulty in intubation, requirement of release of neck collar and complications, if any.

 


AIMS AND OBJECTIVES

 

Aim:

To evaluate the performance of McGrath® videolaryngoscope, GlideScope®  laryngoscope and compare these with conventional Macintosh laryngoscope for endotracheal intubation after applying cervical collar to simulate a cervical spine injury scenario in adult patients with normal cervical spine who are about to undergo surgery requiring general anaesthesia with tracheal intubation.

 

Objectives:

To study and compare the following parameters using McGrath® videolaryngoscope, GlideScope® laryngoscope and Macintosh laryngoscope:-

·         Success rate of intubation in the first attempt

  • Time for successful intubation
  • Glottic view according to POGO score and C&L grading
  • Number of intubation attempts
  • Difficulty in laryngoscopy
  • Difficulty in intubation
  • Requirement of release of neck collar
  • Complications, if any

 


MATERIALS AND METHODS

 

The proposed study will be conducted in Department of Anaesthesiology and Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi after obtaining approval from the institutional ethics committee.

 

Study Design:

This prospective randomized, single blind controlled trial will be undertaken after taking written informed consent from all the participating subjects.

 

Patient Selection:

A total of 60 patients of either sex posted for elective surgical procedures requiring general anaesthesia with tracheal intubation will be studied.

 

Inclusion criteria

-        Age between 18-60 years.

-        ASA physical status I-II.

Exclusion criteria

-        Patients who do not give consent to participate in the trial

-        Cervical spine disorders

-        Patients requiring surgeries of oral cavity, larynx, pharynx and neck.

 

 

Randomization and Group Allocation:

The patients will be randomly allocated to one of the three groups by using a computer generated random number table. The groups will be allocated depending on the laryngoscope selected for use.  Size of the blade and the ETT will be chosen as per standard guidelines and patient profile.

Group

Device

Number of Patients

MAC

Macintosh Laryngoscope

20

MVL

McGrath® videolaryngoscope

20

GVL

GlideScope®  videolaryngoscope

20

 

Procedure:

A written informed consent for participation in the study will be taken. Preoperative evaluation of patients will be done as per standard protocol. Airway assessment will be done and Mallampati class, thyromental distance, inter incisor gap and any restriction in flexion and extension movements of the neck will be noted. Patients will be kept nil per orally overnight before surgery, as per usual practice. Tablets Alprazolam 0.25 mg and Ranitidine 150 mg will be administered in the night before and morning of surgery with a few sips of water.

In the operating room, lead II electrocardiography, pulse oximetry and non-invasive oscillometric blood pressure monitoring will be started. Cervical collar will be applied on the patients just prior to induction of anaesthesia. General anaesthesia will be induced using morphine 0.1 mg/kg i.v. and propofol 2.0-2.5 mg/kg i.v. After ensuring successful bag mask ventilation, vecuronium 0.1 mg/kg i.v. will be administered to facilitate laryngoscopy and placement of the ETT. Capnography will be instituted after induction of anaesthesia. Laryngoscopy and intubation will be attempted under full muscle relaxation. Patients will be ventilated with 33% O2 in N2O and isoflurane.

All patients will be placed with head in the neutral position. Laryngoscopy will be performed by anaesthesiologists proficient in using the laryngoscope selected for a particular group taking care not to extend the cervical spine. Proficiency in using a particular type of laryngoscope shall be said to be acquired after the anaesthesiologist has performed at least 25 intubations with that particular laryngoscope. 

The laryngoscopic view will be graded according to the POGO score (10, 11) and Cormack and Lehane grading (12).

 

POGO score (10, 11)

The percentage of glottic opening (POGO) score represents the portion of the glottis visualized. It is defined anteriorly by the anterior commisure and posteriorly by the inter-arytenoid notch. The score ranges from 0% when none of the glottis is seen to 100% when the entire glottis including the anterior commisure is seen.

 

Fig 2

Figure 1: The percentage of glottic opening (POGO) score for representation of the portion of glottis visualized.

Cormack and Lehane Grading system (12)

Four laryngoscopic grades are described in Cormack and Lehane Grading system.

Grade I: Most of the glottis is visible.

Grade II: Only the posterior extremity of the glottis is visible.

Grade III: Only the epiglottis is seen.

Grade IV: Epiglottis is not seen.

 

Intubation will be attempted using an appropriately sized styletted ETT. Correct placement of ETT will be confirmed by auscultation and appearance of ETCO2. Time to successful intubation will be recorded and ETT will be fixed after confirming equal air entry in bilateral lung fields.

Difficulty in both laryngoscopy and intubation will be rated according to the grades defined as below:

 

Difficulty in Laryngoscopy

If laryngoscopy is found to be difficult, increased anterior force with laryngoscope or change of blade to one size higher can be used to facilitate laryngoscopy.  A bougie can also be used as an intubating aid, if required.

Laryngoscopy difficulty score:-

Grade I: Easy Laryngoscopy without any maneuver

Grade II: Laryngoscopy requiring an increased anterior force

Grade III: Change of laryngoscope blade to one size higher

Grade IV: Change of laryngoscope blade used with an increased anterior force

Difficulty in Intubation

Difficulty in intubation will be defined by Intubation difficulty score, as follows:-

Grade I: Intubation easy

Grade II: Intubation possible with change of blade size or increased anterior force

Grade III: Requirement of Bougie for intubation

Grade IV: Requirement of release of neck collar

In case, intubation requires release of neck collar i.e., Grade IV, it will be considered as failure to intubate with the particular laryngoscope for this study purpose.

Anaesthesia will be maintained according to the standard guidelines practiced for all general anaesthesia cases.

Trauma to lips, teeth, structures in oral cavity and larynx or presence of blood on the laryngoscope blade and ETT will be recorded, if noted at the time of laryngoscopy and intubation, and just before extubation.

 

Number of Intubation attempts

Number of intubation attempts will be noted. If the ETT is withdrawn from oral cavity to be re-inserted, it will be counted as a new attempt. Three attempts will be allowed before the insertion is considered impossible or failed.

 

Time for successful intubation

Time for successful intubation will be defined as the time from start of laryngoscopy to the confirmation of successful ventilation using EtCO2 waveform.

 

Failure to Intubate

When the anaesthesiologist is unable to intubate with neck collar in place and requests the removal of neck collar or there is inability to intubate in three attempts as described above, it would be considered as failure to intubate in the present study.

 

Other variables

The demographic variables, nature of surgery and duration of surgery will also be recorded in all the patients.

 

Sample Size Calculation

Considering a success rate of 100% for McGrath® Videolaryngoscope and 59% for Macintosh laryngoscope according to a previous study in the literature (13), at 90% power and 95% confidence interval a sample of 19 cases in each group is required. Since the success rate for GlideScope® group is not available, the same number of patients will be included in this group also. So we decided to include 20 subjects in each group.

 


REFERENCES

 

1.              Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010;57:588-601.

2.              Brimacombe J, Keller C, Künzel KH, Gaber O, Boehler M, Pühringer F. Cervical spine motion during airway management: a cinefluoroscopic study of the posteriorly destabilized third cervical vertebrae in human cadavers. Anesth Analg. 2000;91:1274-8.

3.              Prasarn ML, Conrad B, Rubery PT, Wendling A, Aydog T, Horodyski M, Rechtine GR. Comparison of 4 airway devices on cervical spine alignment in a cadaver model with global ligamentous instability at C5-C6. Spine (Phila Pa 1976). 2012;37:476-81.

4.              Liu EHC, Goy RWL, Tan BH, Asai T. Tracheal intubation with videolaryngoscopes in patients with cervical spine immobilization: a randomized trial of the Airway Scope and the GlideScope® . Br J Anaesth 2009;103:440-51.

5.              Hyuga SSekiguchi TIshida TYamamoto KSugiyama YKawamata M. Successful tracheal intubation with the McGrath(®) MAC video laryngoscope after failure with the Pentax-AWSâ„¢ in a patient with cervical spine immobilization. Can J Anaesth. 2012 Sep 22. [Epub ahead of print]

6.              Hughes CGMathews LEasdown JPandharipande PP. The McGrath® video laryngoscope in unstable cervical spine surgery: a case series. J Clin Anesth. 2010 Nov;22(7):575-6.

7.              Cuchillo JVRodríguez MA. Intubation with the GlideScope®  videolaryngoscope in a man with severe cervical spondylolisthesis. Rev Esp Anestesiol Reanim. 2005 Aug-Sep;52(7):425-8. [Article in Spanish]

8.              Wetsch WA, Carlitscheck M, Spelten O, Teschendorf P, Hellmich M, Genzwürker HV, Hinkelbein J. Success rates and endotracheal tube insertion times of experienced emergency physicians using five video laryngoscopes: a randomised trial in a simulated trapped car accident victim. Eur J Anaesthesiol. 2011;28:849-58.

9.              Wetsch WA, Spelten O, Hellmich M, Carlitscheck M, Padosch SA, Lier H, Böttiger BW, Hinkelbein J. Comparison of different video laryngoscopes for emergency intubation in a standardized airway manikin with immobilized cervical spine by experienced anaesthetists. A randomized, controlled crossover trial. Resuscitation. 2012 Jun;83(6):740-5. Epub 2011 Dec 7.

10.             Levitan RM, Ochroch EA, Rush S, Shofer FS and Hollander JE. Assessment of Airway Visualization: Validation of the Percentage of Glottic Opening (POGO) Scale. Acad Emerg Med 1998; 5: 919–23.

11.             Levitan RM. Direct laryngoscopy imaging: teaching and research applications. Am J Anesthesiology 1999; 26: 39–42.

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

13.             Taylor AM, PeckM, Launcelott S, Hung OR, Law JA, MacQuarrie K, McKeen D, George RB, Ngan J. The McGrath® Series 5 videolaryngoscope vs the Macintosh laryngoscope: a randomised, controlled trial in patients with a simulated difficult airway. Anaesthesia 2013;68:142–147.

 
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