| 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 |
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Crae, JNMCH, AMU, Aligarh
UP- 202002 |
|
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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 |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| 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, |
|
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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 |
|
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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) |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic changes i.e. HR , MABP and RPP using VLSCOPE, Light wand and Macintosh Laryngoscope |
4 months |
|
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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 |
|
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Not yet available |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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.
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