FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/09/021176 [Registered on: 11/09/2019] Trial Registered Prospectively
Last Modified On: 09/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Haemodynamic derangements during laryngoscopy using different intubating devices 
Scientific Title of Study   A PROSPECTIVE RANDOMIZED STUDY FOR COMPARATIVE EVALUATION OF HAEMODYNAMIC DERANGEMENTS USING VLSCOPE (VIDEO LARYNGOSCOPE), LIGHT WAND AND CONVENTIONAL MACINTOSH LARYNGOSCOPE AS INTUBATING DEVICES IN ADULT SURGICAL PATIENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zoya Khan 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College and Hospital,AMU, Aligarh 
Address  Department of Anesthesiology and Critical Care JNMCH AMU Aligarh UP - 202002 India
88/387 Naala Road, Chamanganj, Kanpur Kanpur Nagar UP - 208001
Kanpur Nagar
UTTAR PRADESH
202002
India 
Phone  9045460062  
Fax    
Email  itzee.zoe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Qazi Ehsan Ali 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh 
Address  Department of Anesthesiology and Critical Care JNMCH AMU Aligarh UP - 202002 India

Aligarh
UTTAR PRADESH
202002
India 
Phone  9045460062  
Fax    
Email  qaziehsanali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Zoya Khan 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh 
Address  Department of Anesthesiology and Critical Care JNMCH, AMU Aligarh UP - 202002

Aligarh
UTTAR PRADESH
202002
India 
Phone  9045460062  
Fax    
Email  itzee.zoe@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Crae, JNMCH, AMU, Aligarh UP- 202002 
 
Primary Sponsor  
Name  Department of Anesthesiology and Critical Care 
Address  Department of Anesthesiology and Critical Care, JNMCH, AMU, Aligarh, UP - 202002 
Type of Sponsor  Government medical college 
 
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 
Zoya Khan  JNMCH  Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh
Aligarh
UTTAR PRADESH 
9045460062

itzee.zoe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (3) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (4) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (5) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (6) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (7) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Light Wand  Light Wand- Illuminating lightened stylet 
Comparator Agent  Macintosh Laryngoscope  Coventional Larygnscopy blade 
Intervention  VLSCOPE  VLSCOPE - Video Laryngoscope 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Weight (40-70 kgs)
ASA Grade I and II
Patients posted for Elective surgery 
 
ExclusionCriteria 
Details  Patient with previous history of multiple/failed intubation
Patient with predicted difficult laryngoscopy (except for MP Grade III and IV)
Patient with known or suspected cardiovascular derangement
Patients with any pathology of oral cavity that may obstruct the insertion of device
Mouth openning of less than 2.5 cm
Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurtitation and heart burn) and at risk of esophageal reflux (Hiatus Hernia) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the haemodynamic changes i.e. HR , MABP and RPP using VLSCOPE, Light wand and Macintosh Laryngoscope   4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for intubation
Success rate of intubation
Number of attempts taken for intubation
Number of adjustment maneuvers needed for successfull intubation
Grade the ease of intubation in three different devices
Record the evidence of airway trauma
Document the incidence of sore throat in postoperative period 
4 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   23/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet available 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


 A  PROSPECTIVE RANDOMIZED  STUDY FOR COMPARITIVE  EVALUATION  OF  HAEMODYNAMIC DERANGEMENTS  USING  VLSCOPE (VIDEO LARYNGOSCOPE), LIGHT WAND AND CONVENTIONAL MACINTOSH  LARYNGOSCOPE AS  INTUBATING  DEVICES  IN ADULT  SURGICAL  PATIENTS.

Zoya Khan**, Qazi Ehsan Ali*

Department of Anesthesiology and Critical Care, JNMCH, AMU, Aligarh

**Presenting author, * Professor



INTRODUCTION

The technique of laryngoscopy consists of proper positioning, opening of the mouth, inserting the laryngoscope blade, positioning it in the valleculla and applying force to raise the epiglottis and then insert the endo-tracheal tube through the vocal cords into the trachea. One of the most teleological functions of the larynx is that of airway protection, which is primarily provided by means of glottic closure reflex Apart from the airway, this process induces various changes in different physiological systems of the body.

 

Laryngoscopy and intubation are an intense noxious stimulus for the body. Among the various systems, of importance is the cardio vascular system, wherein the response occurs via the vagal and the glossopharyngeal afferents that result in a reflex autonomic activation. This manifests as reflex tachycardia and hypertension in adults and adolescents, whereas autonomic activation in children and infants results in reflex bradycardia.

 

The heart rate and blood pressure are known to fluctuate in the post intubation period. Another parameter is the Rate–pressure product (RPP), it was originally described by Katz & Feinberg (1958) as an index of ‘cardiac effort’ and correlation with oxygen consumption was confirmed in humans by Kitamura et al. (1972). RPP is linearly correlated with oxygen consumption. It is of equal importance in cardiac compromised patients.

 

Studies have also established that the magnitude of cardiovascular response is related to the force applied to lift the glottis and the duration of laryngoscopy. All this being established for patients with no co-morbidities present, the knowledge regarding the changes in cardiovascular parameters are of absolute necessity in case any co morbidity factors are present. For example, hypotension is relatively common in patients with poor LV function, hypertension may be induced due to sympathetic stimulation during laryngoscopy; following the stress of tracheal intubation kidney transplant patients may develop hypotension before surgical incision.The resultant sympathetic response and the resulting hemodynamic response have been extensively studied and documented in different patient groups, both with and without cardiac illness.

 

The choice of anesthetic techniques should be selected while keeping the patient’s cardiac patho-physiology and other co-morbid conditions in mind.No single set ‘algorithm’/’recipe’ can guarantee hemodynamic stability during anesthetic induction.

 

 The purpose of the present study is to compare the hemodynamic changes using three different devices, namely the new VLSCOPE (video laryngoscope), Light wand and the conventional Macintosh laryngoscope for as an intubating in elective adult surgical patients.

 

Video laryngoscopy is relatively recent development that improves the success of tracheal intubation. They have revolutionized the practice of airway, and are now included in the ASA “Difficult Airway Algorithm” as an alternative approach to intubation. Numerous studies have already been performed and in place to compare and evaluate the physiological altercations caused by the newer instruments in the ever evolving field of airway management. 


MATERIAL AND METHODS


Elective endotracheal intubation will be carried out in adult sugrical patients using VLSCOPE (video laryngoscope), Light wand and conventional Macintosh laryngoscope in 30 patients in each group.
Haemodynamcis derrangements in terms of  heart rate, mean arterial blood pressure and rate pressure product shall be recoded and are the primary objectives of this study. Furthermore, secondary objectives that include time for intubation, success rate, number of attempts, number of adjustment maneuvers for successfull intubation, ease of intubation, any incidence of airway trauma or any post operative sore throat shall also recorded.
The results will be compared amongst the three groups.

RESULTS

The study will be started after 2 weeks. Above quoted parametres will be recorded and compared.


 
Close