| CTRI Number |
CTRI/2019/02/017777 [Registered on: 22/02/2019] Trial Registered Prospectively |
| Last Modified On: |
12/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
study for the quantitative assessment of the nasal pathway as compared to combined oro-nasal pathway in terms of expired tidal volume when patient is ventilated via face mask under general anaesthesia. |
|
Scientific Title of Study
|
To assess the contribution of nasal passage during face mask ventilation at two different airway pressures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fahina Perveen |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical college |
| Address |
Department of anaesthesiology,
3rd block,
B.L.Taneja block,
Maulana Azad medical college
2-Bahadur Shah Zafar Marg
New Delhi- 110002
Department of anaesthesiology,
3rd block,
B.L.Taneja block,Maulana Azad medical college
2-Bahadur Shah Zafar Marg
New Delhi- 110002
New Delhi
DELHI
110002
India |
| Phone |
9650160578 |
| Fax |
|
| Email |
fahinaperveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J S Dali |
| Designation |
Doctor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
DR. J. S. Dali,
Department of anaesthesiology,
3rd block,
B. L. Taneja block,
Maulana Azad Medical College and associated hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604212 |
| Fax |
|
| Email |
dr_dali@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J S Dali |
| Designation |
Doctor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
DR. J. S. Dali,
Department of anaesthesiology,
3rd block,
B. L. Taneja block,
Maulana Azad Medical College and associated hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604212 |
| Fax |
|
| Email |
dr_dali@rediff.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
2-Bahadur Shah Zafar marg,
New Delhi- 110002 |
| 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 |
| Fahina Perveen |
Maulana Azad Medical College and associated hospital |
Department of anaesthesiology,
Maulana Azad Medical College,
2-Bahadur Shah Zafar Marg,
New Delhi,
Delhi
New Delhi
DELHI |
9650160578
fahinaperveen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients who are ASA grade I/II/III admitted for elective surgery under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparing expired tidal volume with and without nasal occlusion during face mask ventilation |
under general anaesthesia, expired tidal volume will be measured with and without nasal occclusion during face mask ventilation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
male patients aged 18-55 years.
patient planned for elective surgeries under general anaesthesia.
physical status ASA grade I to III |
|
| ExclusionCriteria |
| Details |
obese patients (BMI>30 kg/m2)
patients with short neck
thyromental distance < 6.5 cm
modified mallampatti class > II
Interincisor distance < 3cm
patients with protruding/missing incisors, edentulous patients
history of snoring
bearded patients
patients with evident nasal obstruction
non fasted, emergency case
patients with history of gastroesophageal reflux disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in tidal volume with and without nasal occlusion at two different airway pressures |
1 min readings of expired tidal volume will be taken with and without nasal occlusion at 10 and 15 cm of water, with 1 min of washout between each reading |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2019 |
| Date of Study Completion (India) |
30/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Manual face mask ventilation is an important component of airway management during general anaesthesia. Diffficult face mask ventilation is commonly encountered due to upper airway obstruction. many studies showed the importance of nasal pathway during face mask ventilation. However, there is paucity of studies regarding quantitative assessment with respect to tidal volume contribution via oral and nasal passages. The assessment of nasal passage contribution may help in judicious use of nasal mask and nasal airways to releive upper airway obstruction during mask ventilation. |