CTRI Number |
CTRI/2024/01/061261 [Registered on: 09/01/2024] Trial Registered Prospectively |
Last Modified On: |
04/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare intubation through Intubating Laryngeal mask airway and Laryngeal mask airway Protector during airway management. |
Scientific Title of Study
|
Comparison of Intubating Laryngeal mask airway with that of LMA Protector during airway management in adult patients. A prospective randomized comparative study. |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR PEDIREDDY SOBHA RANI |
Designation |
PG RESIDENT |
Affiliation |
IMS AND SUM HOSPITAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN UNIVERSITY
K8-KALINGA NAGAR, KHORDHA
BHUBANESWAR
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
K8-KALINGA NAGAR, KHORDHA
BHUBANESWAR Khordha ORISSA 751003 India |
Phone |
8790831687 |
Fax |
|
Email |
pedireddyshoba78@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sulochana Dash |
Designation |
Professor |
Affiliation |
IMS AND SUM HOSPITAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN UNIVERSITY
K8-KALINGA NAGAR, KHORDHA
BHUBANESWAR
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
K8-KALINGA NAGAR, KHORDHA
BHUBANESWAR Khordha ORISSA 751003 India |
Phone |
9566841303 |
Fax |
|
Email |
Dr.silu76@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR PEDIREDDY SOBHA RANI |
Designation |
PG RESIDENT |
Affiliation |
IMS AND SUM HOSPITAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN UNIVERSITY
K8-KALINGA NAGAR, KHORDHA
BHUBANESWAR
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
K8-KALINGA NAGAR, KHORDHA
BHUBANESWAR Khordha ORISSA 751003 India |
Phone |
8790831687 |
Fax |
|
Email |
pedireddyshoba78@gmail.com |
|
Source of Monetary or Material Support
|
DEPARTMENT OF ANAESTHESIOLOGY
IMS AND SUM HOSPITAL |
|
Primary Sponsor
|
Name |
IMS AND SUM HOSPITAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR
IMS AND SUM HOSPITAL
SIKSHA O ANUSANDHAN UNIVERSITY
K8-KALINGA NAGAR, KHORDHA |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR PEDIREDDY SOBHA RANI |
IMS AND SUM HOSPITAL |
Department of
Anesthesiology ,First floor,K8,Kalinganagar
Bhubaneswar Khordha ORISSA |
8790831687
pedireddyshoba78@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE ,IMS AND SUM HOSPITAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intubating Laryngeal mask Airway |
To compare the ease of intubation and time taken for intubation,adequacy of airway seal,oropharyngeal leak pressure,ease of gastric tube placement,incidence of post operative sore throat.Total duration of study 1.5years |
Comparator Agent |
Laryngeal mask airway Protector |
To compare the ease of intubation and time taken for intubation,adequacy of airway seal,oropharyngeal leak pressure,ease of gastric tube placement,incidence of post operative sore throat |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Adult patient between the age of 18 – 60 years
2.ASA grade one and two
3.Patient is posted for elective surgery under general anesthesia.
|
|
ExclusionCriteria |
Details |
1.Age more than 60 years
2.ASA grade three and four
3.Patients with maxillofacial trauma and anomalies
4.Patients with restricted neck movements
5.Obesity BMI more than 40kg/m2
6.Limited mouth opening
|
|
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 ease of intubation, number of attempts and time taken for intubation through Intubating laryngeal mask airway and Laryngeal mask airway protector |
Time at insertion of Laryngeal mask airway taken as Time 0
Time taken for insertion of ET tube through Laryngeal mask airway is noted
Appearence of capnograph is taken as endtime |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare ease of insertion of SAD, adequacy of airway seal, oropharyngeal leak pressure, ease of gastric tube placement, incidence of post-operative sore throat. |
Oropharyngeal leak pressures at time of insertion & 10 mins after insertion
post operative 2hour vitals & sore throat within 24hs monitoring. |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 3/ Phase 4 |
Date of First Enrollment (India)
|
15/01/2024 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This study will be conducted at our institution over a period of 1.5 years. In this study 80 ASA grade I and II patients between age 18 to 60 years with BMI<35kg/m2 posted for elective surgeries requiring general anesthesia will be included. After taking written informed consent patients will be randomized to two groups (n=80) by computer generated random number table by the anaesthesiologist who is not involved in the procedure. All patients will be thoroughly examined pre-operatively including detailed airway examination and ASA grading. Patients will be kept Nil per oral from night before surgery. Patients will be shifted to the operation room (OR) on the day of surgery. Intravenous (IV) line will be secured with 18G IV cannula. ASA standard monitors eg. electrocardiograph (ECG), Noninvasive blood pressure (NIBP) and Arterial oxygen saturation (SpO2) will be attached and all patients will be premeditated with IV glycopyrrolate 0.05mg/kg and IV midazolam 0.03 mg/kg, 10 minutes before induction of anaesthesia. Induction will be done with IV fentanyl 2mcg/kg and IV propofol 2.5 mg/kg. After assessing adequate mask ventilation, muscle relaxation will be facilitated with atracurium 0.5 mg/kg, mask ventilation will be continued for 3 minutes. Then according to allocated group proper size SAD will be selected as per body weight. Both devices will be lubricated using 2% lignocaine jelly and the both SAD fully deflated prior to insertion. ILMAâ„¢ or LMA P will be inserted in neutral neck position. After SAD insertion, confirmation of successful ventilation will be confirmed by continuous square waveform capnography. The numbers of attempts and time required for SAD insertion will be recorded. A failed attempt was defined as removal of the SAD from the mouth before reinsertion. After achieving successful ventilation with SAD, blind ET intubation was attempted using both the devices. If no resistance is felt ET tube will be advanced fully into the SAD. When resistance is felt during ET tube insertion, following maneuvers will be tried in LMA P group: 1) Twisting of the ET tube to align the bevel, up and downward movement of the ET tube gently within the SAD. 2) Application of cricoid pressure (Bhandari G et al. [6]). If resistance is felt during insertion of ET tube in ILMA group, a standardized algorithm [4] will be followed on the basis of the distance at which the resistance is felt and other maneuvers which can be includes: optimizing the airway, rotating the ET tube bevel, adjusting head neck position and adding air to the cuff. Duration of successful ET intubation through SAD is defined as the time elapsed from picking of the ET tube by hand and placing it through SAD until confirmation of square waveform capnography (ETCo2). Airway seal will be checked as: Excellent -No audible leak, Good-Some audible leak present, but ventilation is adequately maintaining ETCO2<40mm/Hg. Poor-Relevant loss of air with insufficient ventilation requiring reposition of devices. Orogastric tube placement will be done using SAD. Easily passing gastric tube through SAD will be confirmed by suctioning of gastric contents. In all patients, procedure will be performed by the same experienced anaesthesiologist who has done a minimum 50 successful SAD insertions. Ease of insertion, No. of attempts, time taken for ETT placement through ILMA and LMA P will be recorded. Adequacy of airway seal and oropharyngeal leak pressure will be noted for analysis. Anaesthesia will be maintained with Isoflurane (1 vol%) in oxygen/nitrous oxide (50%/50%) mixture using closed circuit in low flow (1lit). Intermittent bolus of atracurium for muscle relaxation and fentanyl for analgesia will be used. Inta operative monitoring of vitals, Input output charting will be done. At the end of surgery, neuromuscular blockade is reversed with a mixture of glycopyrrolate (0.01 mg/kg) and neostigmine (0.05 mg/kg) and extubation will be done after adequate reversal. Patient will be shifted to recovery room for 30mins observation. Post-operative monitoring, anlgesia and PONV prophylaxis will be given. In post-operative period two hours vitals monitored and patients asked about post operative sore throat incidence in 24hrs and noted for analysis. | |