| CTRI Number |
CTRI/2018/01/011349 [Registered on: 16/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between airway nerve blocks vis-à -vis spray-as-you-go technique for awake nasotracheal intubation in anticipated difficult airway using portable fibrescope’ |
|
Scientific Title of Study
|
Comparison between airway nerve blocks vis-à -vis spray-as-you-go technique for awake nasotracheal intubation in anticipated difficult airway using portable fibrescope’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surg Capt Manish Honwad |
| Designation |
Associate Professor , Dept Of Anaesthesiology And Critical Care, Armed Forces Medical College, Pune |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Associate Professor , Dept Of Anaesthesiology And Critical Care, Armed Forces Medical College, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9930621135 |
| Fax |
|
| Email |
honwadms@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Shayam Prakash Panjiyar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept Of Anaesthesiology and Critical Care, Armed Forces Medical College,Solapur Road Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9879246771 |
| Fax |
|
| Email |
sppanjiyarmeerut@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maj Shayam Prakash Panjiyar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept Of Anaesthesiology and Critical Care, Armed Forces Medical College,Solapur Road Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9879246771 |
| Fax |
|
| Email |
sppanjiyarmeerut@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology and Critical Care Armed Forces Medical College
SOLAPUR ROAD
PUNE-411040 |
| Type of Sponsor |
Government 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 Surg Capt Manish Honwad |
Armed Forces Medical College |
Armed Forces Medical College
Command Hospital(Southern Command)Solapur Road,Pune-411040
Pune
MAHARASHTRA |
9930621135
honwadms@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,AFMC,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I, II patients.
(b) Age group18yrs – 60 years
(c) Anticipated difficult airway as assessed
in PA assessment., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(a) ASA grade I, II patients
(b) Age group18yrs – 60 years
(c) Anticipated difficult airway as assessed
in PA assessment
|
|
| ExclusionCriteria |
| Details |
(a) Uncooperative patients.
(b) Asthmatics/Epileptics
(c) Deranged coagulation
(d) Haemodynamic instability/Bradyarrythmias
(e) Infection at the local site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for intubation,by two methods of airway anaesthesia namely airway nerve blocks and topical spray-as-you-go technique for anaesthesia in the performance of awake nasotracheal intubation using flexible videoscope in anticipated difficult airway. |
1)Time to vocal cord visualization
2)Time to tracheal intubation
3)Total time of nasotracheal intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic variables at baseline and during the procedure bytwo methods of airway anaesthesia. .
|
1)Before intubation
2)At the time of intubation
3)After intubation
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/11/2016 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a longitudinal observational study aimed at comparing the time taken for intubation in anticipated
difficult airway with two different airway anaesthesia techniques and also
haemodynamic parameters and patient comfort in both groups. A study in this
regard will act as a guide to the anaesthesiologist to decide the type of
airway airway anaesthesia preferred with respect to ease of intubation and
patient comfort..
|