| CTRI Number |
CTRI/2024/01/061057 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To study whether COPUR INDEX can be used during difficult videolaryngoscopy and intubation in paediatric patient |
|
Scientific Title of Study
|
Prospective observational study to determine the predictive value of COPUR INDEX for ease of videolaryngoscopy and intubation in paediatric patient |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Writuparna ray |
| Designation |
Juniour Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be university Medical College |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Medical College
Pune Satara road,Dhankawadi,
Pune
MAHARASHTRA
411043
India |
| Phone |
8240563406 |
| Fax |
|
| Email |
season.ray17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalyani Nilesh Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university Medical College |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Medical College
Pune Satara road,Dhankawadi,
Pune
MAHARASHTRA
411043
India |
| Phone |
9673400066 |
| Fax |
|
| Email |
kalyanish19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalyani Nilesh Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university Medical College |
| Address |
Department Of Anaesthesia
Bharati Vidyapeeth Medical College
Pune Satara road,Dhankawadi,
Pune
MAHARASHTRA
411043
India |
| Phone |
9673400066 |
| Fax |
|
| Email |
kalyanish19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharti Hospital and research center |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Center |
| Address |
Pune-Satara Road,Dhankawadi,Pune
Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
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 Writuparna Ray |
Bharati Hospital and Research Center |
Department of Anaesthesia
Bharati Vidyapeeth Medical College
Pune Satara Road, Dhankawadi
Pune
MAHARASHTRA |
8240563406
season.ray17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Instutional Ethical Committee |
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 |
Videolaryngoscopy and Intubation |
We will measure COPUR SCORE of Paediatric patient in pre-op,then we will do Videolaryngoscopy in intra-op and measure whether intubation will be difficult or not |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patient who all are undergoing surgery under general anaesthesia
ASAI and ASAII
COPUR SCORE <10 |
|
| ExclusionCriteria |
| Details |
known difficult airway includingcongenital upper airway malformation, swelling in head and neck region,scars,dressing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study co-relation between COPUR INDEX & POGO on videolaryngoscopy& ease of intubation.
|
We will access COPUR Score in Preoperative room.POGO score and ease of intubation will be accessed by doing videolaryngoscopy in operative room on the same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate the COPUR INDEX with the need of manipulation to improve
POGO And with the need of manipulation for intubation
|
We will access COPUR Score in preoperative room & it’s correlation with external manipulation of POGO & intubation in operative room on the same day |
|
|
Target Sample Size
|
Total Sample Size="147"
Sample Size from India="147"
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)
|
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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ethical approval will be obtained for the study from the ethics committee Patients are selected preoperatively based on inclusion and exclusion criteria .Once the patient enters the preoperative room,the patient"s parents will be informed about the study in a langue they fully comprehend.They will be given patient information sheet and will be enrolled in the studyafter taking a written informed consent and additional assent will be taken from children age group 8-15years. Vitals parameters will be measured. COPUR score.We assessed the COPUR SCORE of patient will be assessed in preoperative room,by a separate anaesthesiologist who will not be a part of further study. After assessing the COPUR SCORE in preoperative room,patient with score <10 will receive Premedication :Inj glycopyrrolate 0.004mg/kg, Inj. Ketamine 0.3-0.5mg/kg,Inj Midazolam 0.02mg/kg intravenous. Patient shifted to operation theater under standard MAC protocols.After shifting patient to operation theatre, following monitors will be attached – ECG, NIBP, SPO2. Baseline readings for pulse, blood pressure, SPO2 wil be recorded. Pre Induction: Inj. Fentanyl -1μg/kg ,Induction:Inj. Propofol – 2 mg/kg.Neuromuscular Blocking agent- Inj. Atracurium 0.5 mg/kg.After the administration of a neuromuscular blocking agent, the glottic view will be obtained by lifting the epiglottis using VL with a curved blade.The POGO will be noted. The need of external laryngeal manipulation will be noted.Intubation will be performed with appropriate size of ET tube.The need for any manipulation or intubation aids required will be noted. The time of intubation will be defined as time from insertion of Videolaryngoscope to the first ETCO2 graph.Number of intubation attempts for successful intubation will be noted. Assessment of COPUR INDEX & VIDEOLARYNGOSCOPY will be done by two different Anaesthesiologist. |