| CTRI Number |
CTRI/2024/04/065380 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Number of patients having difficult mask ventilation and difficult insertion of ventilation tube into the windpipe during open heart surgery (bypass surgery) |
|
Scientific Title of Study
|
Incidence and predictors of difficult mask ventilation and intubation in patients scheduled for coronary artery bypass surgery – a prospective observational 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 Aneesha Chris Wilfred |
| Designation |
Post Graduate Registrar |
| Affiliation |
Christian Medical College |
| Address |
Junior Resident,
Room no: 107,
Department of Anesthesiology,
Christian Medical College, Vellore 632004
Vellore TAMIL NADU 632004 India |
| Phone |
9487267076 |
| Fax |
|
| Email |
aneeshawilfred@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Room no:2105,
Department of Anesthesiology,
Christian Medical College,
Vellore 632004
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Room no: 2105,
Department of Anesthesiology,
Christian Medical College,
Vellore 632004
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant,
Christian Medical College,
Vellore 632004,
Tamil Nadu,
India |
|
|
Primary Sponsor
|
| Name |
Dr Aneesha Chris Wilfred |
| Address |
Post Graduate Registrar,
Room no: 107
Junior Resident,
Department of Anesthesiology,
Christian Medical College,
Vellore 632004,
Tamil Nadu,
India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Aneesha Chris Wilfred |
Christian Medical College and Hospital |
Cardiothoracic surgery operation theatre,
Department of Anesthesiology,
Vellore 632004 Vellore TAMIL NADU |
9487267076
aneeshawilfred@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College, Vellore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 to 70 years
2.ASA 3 and ASA 4 patients undergoing Coronary Atery Bypass Grafting (CABG)
3.BMI more than 18
4.Ability to understand protocol and give informed consent |
|
| ExclusionCriteria |
| Details |
1.Patients who are planned for Rapid Sequence Induction (RSI)
2.Patients who are on tracheostomy tube
3.Pregnant patients
4.Patients who do not consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of difficult mask ventilation and intubation in patients undergoing coronary artery bypass surgery using difficult mask ventilation grading and Intubation difficulty scale |
At the time of induction of anesthesia in the operation theatre |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the predictors of difficult mask ventilation and intubation in patients undergoing coronary artery bypass surgery
To assess the correlation of clinical prediction of difficult airway with difficult mask ventilation and difficult intubation. |
Preoperatively in the ward where patients are admitted.
Intraoperatively at the time of mask ventilation and intubation |
|
|
Target Sample Size
|
Total Sample Size="175" Sample Size from India="175"
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)
|
17/04/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Difficult airway is defined as ‘’the clinical situation in which a
conventionally trained anesthesiologist experiences difficulty with face mask
ventilation of the upper airway, difficulty with tracheal intubation or both.’’
Predictors of difficult airway include age, sex, BMI, ASA classification,
external signs like, facies, facial hair, body habitus, head and neck
pathology, airway examination including cervical spine mobility ,dentition,
thyromental distance, sternomental distance, jaw protrusion, mallampatti
classification, neck circumference, history of snoring.
Patients undergoing coronary artery bypass grafting invariably have
physiologically low cardiac reserve. They are also mostly associated with
obesity, diabetes mellitus, hypertension, metabolic syndrome making them
difficult airways. Duration of successful intubation (DSI) in these high risk
patients should be less in order to prevent adverse events on myocardial
oxygenation while securing the airway. Therefore it is essential to
preoperatively clinically assess the airway and determine the predictors of difficult
mask ventilation and intubation. In this
study we also assess the correlation of our clinical prediction with real time
mask ventilation and intubation.
The ASA originally defined
difficult intubation as requiring more than 3 attempts or taking longer than 10 minutes to complete using
conventional laryngoscopy.
In order to assess difficult tracheal intubation and difficult mask
ventilation there are scales of difficulty. Difficult mask ventilation grading
includes usage of airway adjuncts, 2 hand technique, usage of muscle relaxant.
Intubation difficulty scale includes 7 contributors namely, number of
supplementary attempts, number of supplementary operators, alternative
techniques used, glottic exposure (Cormack and lehane grading), lifting force
applied during laryngoscopy, necessity of external laryngeal pressure and
position of the vocal cords. Duration of successful intubation is also taken
into account.
Patients undergoing
coronary artery bypass graft surgery can have higher incidence of difficult
airway. Awareness about the incidence and predictors of difficult airway in
CABG patients will help the anesthesia provider in being adequately prepared
for management of a difficult airway situation thereby reducing the
laryngoscopy related adverse events on myocardial oxygenation.
Hence in this
observational study we will be clinically assessing the airway of patients
undergoing coronary artery bypass surgery preoperatively and determine the
difficulty of mask ventilation and intubation. |