| CTRI Number |
CTRI/2020/11/029327 [Registered on: 24/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Anticipation of difficult mask ventilation by using exhaled carbon dioxide based grading system |
|
Scientific Title of Study
|
Clinically predicted anticipated difficult mask ventilation and its actual occurrence determined using capnographic grading based objective scoring system: An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWATI CHHABRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor OT complex, OPD building AIIMS, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Department of Anaesthesiology and Critical Care, 3rd floor OT complex, OPD building AIIMS, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7340033034 |
| Fax |
|
| Email |
schhabra0209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayan Roy |
| Designation |
PG student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor OT complex, OPD building AIIMS, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7407858524 |
| Fax |
|
| Email |
jayan.edunix@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayan Roy |
| Designation |
PG student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor OT complex, OPD building AIIMS, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7407858524 |
| Fax |
|
| Email |
jayan.edunix@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jayan Roy |
AIIMS Jodhpur |
Department of Anaesthesiology and Critical Care, 3rd floor OT complex, OPD building, AIIMS, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN |
7407858524
jayan.edunix@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (>18years), ASA physical status 1 to 4 scheduled to undergo surgical/ diagnostic procedure under general anaesthesia . |
|
| ExclusionCriteria |
| Details |
1.Patient’s refusal to participate
2.Planned for rapid sequence induction
3.No plan to administer neuromuscular blocking drugs (NMBD) for securing airway (awake intubation, already intubated, tracheostomized patient)
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find association between clinically anticipated and actual difficult mask ventilation using capnographic grading based objective scoring system |
Baseline, at mask ventilation without NMBD (1 minute), at mask ventilation with NMBD (2 minute) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the objective capnographic score before and after neuromuscular blockade, to internally validate the objective capnographic scoring system with subjective assessment of mask ventilation and to assess the choice of neuromuscular blocking drug in such scenarios. |
Baseline, at mask ventilation without NMBD (1 minute), at mask ventilation with NMBD (2 minute) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1577" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mask
ventilation remains an essential skill even as new airway equipment continue to
be invented every now and then.It is
a simple, non-invasive technique for ventilation used as a primary mode of
providing anaesthesia for short duration surgery or as a bridge to establish a
definitive airway. Various
clinical parameters are available which help in predicting a difficult mask
ventilation. The
predictors of difficult mask ventilation are not routinely documented during
pre-anaesthetic evaluation and if described, it is usually subjective,
inconsistent and casually mentioned as easy or difficult . We
planned this observational study to determine the actual occurrence of
difficult mask ventilation using capnographic
grading based objective scoring system in clinically predicted anticipated
difficult mask ventilation
|