| CTRI Number |
CTRI/2024/02/062987 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing insertion of tracheal tube through two different routes , one being through nose and the other one through oral route in cases of adenotonsillectomy surgeries |
|
Scientific Title of Study
|
Nasotracheal vs Orotracheal intubation using RAE tubes for adenotonsillectomy surgeries – A clinical 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 Priyanka S |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bangalore |
| Address |
A block, 4th floor , major ot complex , Department of anaestheisa, emale staff room,Kims hospital, vv puram, shankarapura, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9844828926 |
| Fax |
|
| Email |
priya1685@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka S |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bangalore |
| Address |
A block, 4th floor, major ot complex ,Department of anaesthesia,female staff room, Kims hospital, vv puram, shankarapura, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9844828926 |
| Fax |
|
| Email |
priya1685@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka S |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bangalore |
| Address |
A block, 4th floor, major ot complex ,Department of anaesthesia,female staff room, Kims hospital, vv puram, shankarapura, Bangalore
KARNATAKA
560002
India |
| Phone |
9844828926 |
| Fax |
|
| Email |
priya1685@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda institute of medical science , bangalore |
|
|
Primary Sponsor
|
| Name |
kempegowda institute of medical science |
| Address |
KR road, parvathipuram, vishveshwarapura, bengaluru, karnataka |
| 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 Priyanka S |
Kempegowda institute of medical science, bangalore |
A block, 4th floor, Department of Anaesthesia,Major OT complex,Kempegowda Institute Of Medical Science
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9844828926
priya1685@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nasotracheal intubation |
endotracheal tube will be inserted nasally and the effect will be assesed at the end of surgery |
| Intervention |
orotracheal intubation |
endotracheal tube will be inserted orally and the effect will be assessed at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
8.00 Day(s) |
| Gender |
Both |
| Details |
Paediatric patient less than 8 years of age
Posted for elective adenotonsillectomy |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Patients with oro-pharyngeal injuries.
Patients with Cleft lip and palate.
Patients with any other congenital abnormalities of face, nasal cavities and oropharynx.
Patients with Deviated nasal septum.
ASA physical status III-IV,
Limited mouth opening ( |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of advantages and disadvantages of NTT’s and Oral RAE tubes in adenotonsillectomy surgeries |
at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To quantify the advantages & disadvantages of NTT over Oral RAE tubes in adenotonsillectomy surgeries.
To estimate quality of operative field by surgeon using VAS |
at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
25/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/07/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The potential for trauma is inherently greater with Naso Tracheal Intubation than with orotracheal intubation because the tube passes through the narrow nasal passages. It is hypothesized that passage of the nasotracheal tube (NTT) can traumatize nasal passages, causing bleeding, bacteremia, avulsion of a turbinate, or even retropharyngeal dissection. However NTT’s are still the major tubes used in Adenotonsillectomies considering the wider surgical field they assure. With the introduction of oral Ring, Adair and Elwyn tubes and the advantages they offer over NTT’s and equally providing a better surgical view , oral RAE tubes became popular especially in oral surgeries However there are very few studies which compare NTT’s and oral RAE tubes in adenotonsilectomy surgeries. This study is designed to fulfil the above lacunae.
|