| CTRI Number |
CTRI/2018/06/014506 [Registered on: 12/06/2018] Trial Registered Prospectively |
| Last Modified On: |
11/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE STUDY BETWEEN I-GEL AND LMA-CLASSIC IN ANAESTHETISED, SPONTANEOUSLY BREATHING ADULT PATIENTS UNDERGOING ELECTIVE SURGICAL PROCEDURES |
|
Scientific Title of Study
|
COMPARATIVE STUDY BETWEEN TWO SUPRAGLOTTIC AIRWAY DEVICES IN ANAESTHETISED, SPONTANEOUSLY VENTILATED ADULT PATIENTS DURING ELECTIVE SURGICAL PROCEDURES |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUPAMA MONDAL |
| Designation |
POST-GRADUATE TRAINEE OF M.D ANAESTHESIOLOGY |
| Affiliation |
KPC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY IN KPC MEDICAL COLLEGE AND HOSPITAL, 1F, RAJA S.C. MULLICK ROAD, JADAVPUR, KOLKATA, WEST BENGAL-700032
Kolkata
WEST BENGAL
700032
India |
| Phone |
8640919687 |
| Fax |
|
| Email |
mondal.anupama8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANJUM NAZ |
| Designation |
ASSOCIATE PROFESSOR IN THE DEPARTMENT OF ANAESTHESIOLOGY IN KPC MEDICAL COLLEGE AND HOSPITAL |
| Affiliation |
KPC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY IN KPC MEDICAL COLLEGE AND HOSPITAL, 1F, RAJA S.C. MULLICK ROAD, JADAVPUR, KOLKATA, WEST BENGAL-700032
Kolkata
WEST BENGAL
700032
India |
| Phone |
9836893073 |
| Fax |
|
| Email |
dranjumnaz@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUPAMA MONDAL |
| Designation |
POST-GRADUATE TRAINEE OF M.D ANAESTHESIOLOGY |
| Affiliation |
KPC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY IN KPC MEDICAL COLLEGE AND HOSPITAL, 1F, RAJA S.C. MULLICK ROAD, JADAVPUR, KOLKATA, WEST BENGAL-700032
Kolkata
WEST BENGAL
700032
India |
| Phone |
8640919687 |
| Fax |
|
| Email |
mondal.anupama8@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC MEDICAL COLLEGE AND HOSPITAL,JADAVPUR,1F,RAJA S.C.MULLICK ROAD,JADAVPUR,KOLKATA-700032 |
|
|
Primary Sponsor
|
| Name |
KPC MEDICAL COLLEGE AND HOSPITAL |
| Address |
KPC MEDICAL COLLEGE AND HOSPITAL, 1F, RAJA S.C. MULLICK ROAD, JADAVPUR, KOLKATA, WEST-BENGAL-700032 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANUPAMA MONDAL |
KPC MEDICAL COLLEGE AND HOSPITAL |
OPERATION THEATRES IN KPC MEDICAL COLLEGE AND HOSPITAL,DEPARTMENT OF ANAESTHESIOLOGY, 1F, RAJA S.C. MULLICK ROAD, JADAVPUR, KOLKATA, WEST BENGAL-700032
Kolkata
WEST BENGAL |
8640919687
mondal.anupama8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) OF KPC MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American Society of Anaesthesiologists (ASA) grade I-II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Classical LMA(CLMA) |
Classical LMA(CLMA) consists of an inflatable silicone mask with a connecting tube,inserted blindly into the pharynx with index finger.It forms a low pressure seal around the laryngeal inlet.The total duration of therapy is 2 years |
| Intervention |
I-gel airway |
The I-gel is a single use,novel newer supraglottic airway device for use during anaesthesia with a noninflatable cuff,composed of soft gel like,transparent thermoplastic elastomer.It is designed to achieve a mirror impression of pharyngeal and laryngeal structures and to provide a perilaryngeal seal without cuff-inflation.The I- gel has several other useful design features including a gastric channel,an epiglottic ridge and a widened flattened stem with a rigid(integral) bite block.I-gel has also been used as a conduit for tracheal intubation.The total duration of therapy is 2 years |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
The surgical procedures taken into consideration are
1) Adult patients of either sex aged between (15-60) years.
2) American Society of Anaesthesiologists (ASA) grade I-II
3) Mallampatti (MP) grade I and II
4) Body Mass Index (BMI) between (20-25) kg/m²
5) Scheduled for elective surgeries under general anaesthesia, not requiring muscle relaxation.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
The following patients will be excluded from the study
1) Age < 15 years and > 60 years.
2) American Society of Anaesthesiologists (ASA) grade III and IV
3) Mallampatti (MP) grade 3 and 4
4) Patients having any abnormality of the neck, anticipated difficult airway.
5) Mouth opening < 2 cm.
6) Upper respiratory tract infection.
7) History of Obstructive Sleep Apnoea.
8) Obese patients with Body Mass Index (BMI) > 28 kg/m²
9) Patients with increased risk of aspiration.
10) Duration of surgery > 1 hour.
11) Pregnant females.
12) Patients with reported history of hypersensitivity for one or more medications and latex.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVES
To study and compare two supraglottic airway devices, I-gel and Classical laryngeal mask airway, in anaesthetized adult patients with spontaneous ventilation during elective surgical procedures, with respect to
1) Time taken for insertion.
2) Number of insertion attempts.
3) Ease of insertion, any manipulations required.
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Maintenance of airway with minimal complications is utmost priority of anaesthesiologist during anaesthesia to provide adequate ventilation to the patient. Endotracheal intubation is the gold standard method for this purpose, but some undesirable complications are associated with it e.g, haemodynamic instability as it requires laryngoscopy. Laryngeal Mask Airway(LMA) has revolutionized airway management and is an excellent alternative to mask ventilation and tracheal intubation during General Anaesthesia (GA). I-gel has been designed to improve efficacy in terms of airway-seal and safety in terms of protection from gastric aspiration which is not seen in Classic LMA (CLMA). They are easily inserted, better-tolerated with lesser haemodynamic changes, have favorable respiratory mechanics and decreased airway morbidity with minimal risk of tissue compression. As the elimination of cuff inflation shorten insertion-time, it is advantageous to be used during Cardio Pulmonary Resuscitation (CPR) by non-anaesthetists and in emergency situations requiring prompt airway care in which time is very-important. Therefore,this prospective, randomised,comparative study will be carried out in 100 anaesthetised spontaneously breathing adult patients of both genders, aged between (15-60) years with American Society of Anesthesiologists (ASA) physical status I or, II and Mallampatti grade I or II, posted for elective surgeries under General Anaesthesia (GA) using either the I-gel or, Classic LMA (CLMA) at operation theatres in KPC MEDICAL COLLEGE AND HOSPITAL for 2 years. We will compare the safety and efficacy of I-gel and CLMA regarding the device-insertion parameters (like, insertion time, number of insertion attempts and ease of insertion), perioperative haemodynamic parameters like Heart Rate, Non invasive Blood Pressure, Oxygen saturation (SPO2) and End tidal CO2 (EtCO2) due to device insertion. Appropriate statistical methods will be applied. |