| 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
|
|
|
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
|
|
|
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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