| CTRI Number |
CTRI/2023/08/056115 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
06/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of different types of endotracheal tubes to facilitate nasal intubation in patients undergoing head and neck surgeries. |
|
Scientific Title of Study
|
Comparative study of Flexometallic tube,RAE Tube versus PVC Machintosh Endotracheal Tube using Nasopharyngeal airway to facilitate nasotracheal intubation in patients undergoing head and neck surgeries. |
| 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 Prakruthi D |
| Designation |
Assistant professor |
| Affiliation |
Kempegowda Institute Of Medical Sciences. |
| Address |
Department of Anaesthesia ,A block 4 th floor OT complex .KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Department of Anaestesia, A block 4th floor OT complexKIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9844766997 |
| Fax |
|
| Email |
prakruthi.reddy90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakruthi D |
| Designation |
Assistant professor |
| Affiliation |
Kempegowda Institute Of Medical Sciences. |
| Address |
Department of Anaesthesia , Ablock 4th floor Ot Complex KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Department of Anaesthesia , Ablock 4th floor Ot Complex
KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9844766997 |
| Fax |
|
| Email |
prakruthi.reddy90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakruthi D |
| Designation |
Assistant professor |
| Affiliation |
Kempegowda Institute Of Medical Sciences. |
| Address |
Department Of Anaesthesia A block 4th floor OT complex KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Department Of Anaesthesia A block 4th floor OT complex KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9844766997 |
| Fax |
|
| Email |
prakruthi.reddy90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempgowda Institute of Medical Sciences ,Department of Anaesthesia a block 4th floor OT complex ,Krishna Rajendra Road ,parvathipuram, Vishweshwarapuram ,shankarapura bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
KIMS Hospital |
| Address |
KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002 |
| 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 |
| DrPrakruthi D |
Kempegowda Institute Of Medical Sciences |
Department of Anaesthesia, A block 4th floor Ot complex KIMS Hospital and Research centre, Krishna Rajendra Road , Parvathipuram , Vishweshwarapura,Shankarapura, Bengaluru 560002
Bangalore
KARNATAKA |
9844766997
prakruthi.reddy90@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kempegowda Institute of Medical Sciences |
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 |
group F |
group F intubation with Flexomettalic tube at starting of the surgery.and will be observed till the end of surgery |
| Comparator Agent |
group P |
group P intubation with PVC tube at the starting of the surgery and will be observed till the end of surgery |
| Comparator Agent |
group R |
group R intuabtion with RAE tube at the starting of surgery and will be observed till the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged between 18-60years of either sex.
2.American society Anesthesia ASA physical status 1 and 2.
3.patient scheduled to undergo elective head and neck surgeries. |
|
| ExclusionCriteria |
| Details |
1. Severe facial trauma
2.Fracture of base of the skull
3.coagulopathy
4.nasal deformity or fractures
5.patient refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess & compare ease of insertion of endotracheal tube.
2. To assess & compare bleeding while insertion of nasotracheal tube. |
1.To assess & compare ease of insertion of endotracheal tube. at the starting of the surgery and will be observed till the end of surgery.
2. To assess & compare bleeding while insertion of nasotracheal tube at te starting of the surgery and will be observed till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare for surgical field access among different tubes. |
at the starting of surgery & will be observed till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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 Yet Recruiting |
| 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 is to compare the ease of intubation , trauma, during intubation and better access for surgical field using different types of endotracheal tubes for nasotracheal intubation using nasopharyngeal airway in patients undergoing head and neck surgeries. |