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CTRI Number  CTRI/2020/10/028646 [Registered on: 26/10/2020] Trial Registered Prospectively
Last Modified On: 18/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparison of dual limb circuit with single limb LIMB-O circuit. 
Scientific Title of Study   Comparison of conventional dual limb anaesthesia breathing circuit and single limb partitioned LIMB-O circuit (9 feet) with respect to heat conservation and respiratory dynamics during neurosurgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjana Suresh Pai 
Designation  Junior Resident, Department of Anaesthesiology 
Affiliation  Lokmanya Tikal Municipal Medical College and General Hospital 
Address  Department of anaesthesiology, college building, LTMMC and GH
Department of Anaesthesiology, LTMMC and GH.
Mumbai
MAHARASHTRA
400022
India 
Phone  9870154378  
Fax    
Email  paisanjana14593@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemangi Karnik 
Designation  Professor  
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Department of Anaesthesiology, LTMMC and GH
Dr. Ambedkar Road, sion west, Mumbai- 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9324501900  
Fax    
Email  dr_hemangi@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjana Pai 
Designation  junior resident  
Affiliation  Lokmanya Tilak Municipal Medical College and General College 
Address  Department of Anaesthesiology, LTMMC and GH
Dr. Ambedkar Road, sion west, Mumbai- 400022
Mumbai
MAHARASHTRA
400063
India 
Phone  9870154378  
Fax    
Email  paisanjana14593@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and General Hospital, Dr Babasaheb Ambedkar Road, sion west, Mumbai-400022.  
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Department of Anaesthesia,LTMMC and GH, Sion, Mumbai-400022 
Type of Sponsor  Other [Self] 
 
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 Sanjana Pai  Lokmanya Tilak Municipal Medical College and General Hospital  Department of Anaesthesiology College building Lokmanya Tilak Municipal Medical College and General Hospital,Sion, Mumbai-400022
Mumbai
MAHARASHTRA 
9870154378

paisanjana14593@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe- Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G89-G99||Other disorders of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a)Patient willing to give consent.
b)ASA-I,II,III patients
c)All elective neurosurgeries lasting for more than 4 hours.
d)Surgeries in supine position 
 
ExclusionCriteria 
Details  a)Patients with respiratory diseases or infection.
b)Tracheostomized patients
c)Patients with obstructive sleep apnea
d)Obese patients(BMI>30)
e)Patients with pulmonary aspiration. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the temperature conservation using the conventional dual limb circuit and single limb partitioned LIMB-O circuit  1.Hourly core temperature
2.Hourly skin temperature
3.Temperature difference 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the respiratory dynamics  1.Peak and plateau pressure(15-20 minutes after induction of anaesthesia)
2.PEEP(15minutes after induction of anaesthesia)
3.Resistance
4.Compliance
5.To find any leak in the circuit(using tidal volume inspired and expired) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   20/11/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The anaesthesia breathing system is an assembly of components which connects the patient’s airway to the anaesthesia machine during general anaesthesia. It allows spontaneous, controlled and assisted respiration.

The conventional dual limb circuit has an inspiratory and an expiratory limb.
The newer LIMB-O circuit has a partition separating the inspiratory and expiratory lumens. This permits heat transfer from warm exhaled gases to the inspiratory gases through the partition reducing heat loss from the patient.
Presence of septum decreases the compliance of the circuit ehich allows for delivery of a more accurate tidal volume.

After approval from the Institutional Ethics Committee, all patients undergoing elective neurosurgical procedures under general anaesthesia and satisfying the inclusion and exclusion criteria will be considered for the study.

Thirty consenting patients in whom long LIMB-O circuit is being planned to be used will be included as study group.
Similar number of age, gender and type of surgery matched patients will be included where conventional circuit is to be used.

Standard anaesthesia technique protocol as described below will be followed for all cases.
General anaesthesia will be given in all cases.

PREMEDICATION-  Inj. glycopyrrolate 0.2mg iv, Inj. fentanytl 2mcg/kg iv

INDUCTION- Patient will be preoxygenated for 3 minutes. Patient will be induced with Inj. thiopentone 4-6 mg/kg iv followed by Inj. vecuronium 0.1mg/kg iv. Tracheal intubation with appropriate size cuffed endotracheal tube is attempted.

MAINTENANCE- Anaesthesia is maintained with propofol infusion and oxygen, nitrous oxide (50:50) and isoflurane if needed. Maintenance fresh gas flows is kept at 1L per minute.

Common warming technique will be used for each patient using forced air blowers at 39 degree celsius.

All patients will be ventilated with 6-8 ml/kg tidal volume with volume controlled ventilation to maintain ETCO2 (without PEEP) around 35 mm hg.

For the present study, under these conditions, the parameters to be studied will be noted and compared.

Preoperatively, the baseline resistance, compliance and leak of each of the two circuits will be noted in vitro.

A nasopharyngeal and skin temperature probes will be used to note the patient’s core temperature prior to surgery (after induction), every hour and at the end of surgery. Thus, the heat difference (delta t) will be noted.
One hour after the maintenence flows are set, PEEP, peak and plateau pressures will be noted and 3 consecutive readings of the resistance and compliance of the circuit will be noted.


 
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