| CTRI Number |
CTRI/2024/08/072817 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Study to observe the incidence |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The number of occurrences of a situation of difficult intubation during elective surgery in patients with the disease ankylosing spondylitis (a disease affecting the joints of the spine, neck and jaw). |
|
Scientific Title of Study
|
Incidence and predictors of unanticipated difficult airway in cases of ankylosing
spondylitis – a prospective observation single centric 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 |
Abin Iype |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College And Hospital, Vellore |
| Address |
73-3E7, E1 Block, doctors quarters Kannigapuram, ratnagiri kilminnal
Department of anesthesiology, Christian Medical college, Vellore, 632002.
Vellore
TAMIL NADU
632517
India |
| Phone |
09360575070 |
| Fax |
|
| Email |
abiniype96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajan Philip George |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Department of anesthesiology, Christian Medical college, Vellore.
Vellore
TAMIL NADU
632002
India |
| Phone |
8098118456 |
| Fax |
|
| Email |
sajanpg@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajan Philip George |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Department of anesthesiology, Christian Medical college, Vellore.
Vellore
TAMIL NADU
632002
India |
| Phone |
8098118456 |
| Fax |
|
| Email |
sajanpg@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Institutional Fluid research grant of Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Abin Iype |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore, Tamil Nadu - 632002 |
| 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 |
| Abin Iype |
Christian Medical College, Vellore |
Department of Anesthesiology, Christian Medical College, Vellore, Tamil Nadu - 632002
Vellore
TAMIL NADU |
09360575070
abin.iype.pg@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board and ethics committee of CMC, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M450||Ankylosing spondylitis of multiplesites in spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil comparison planned. |
| Intervention |
nil |
nil intervention planned. Purely observational. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting at any age, with more than 3-month history of back pain, and a
documented positive testing for human leucocyte antigen B27, posted for elective surgery requiring general anesthesia with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Acute or chronic mechanical non-specific back pain and
inflammatory back pain without Spondylarthritis, including disc disease and discogenic
pain syndrome, facet syndrome, radiculopathy, acute bony injuries, spondylolisthesis,
spondylosis, SI joint injuries and lumbar canal stenosis, fibromyalgia, vertebral
compression, or insufficiency related fractures. Other factors causing anticipated difficult airway, such as obvious airway malformations, oral masses, unstable cervical spine, and others requiring emergent surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
incidence of situations of unanticipated difficult airway among cases of ankylosing
spondylitis. |
In the theatre, on the day of planned elective surgery, during the induction of general anesthesia and subsequent intubation. No follow-up required. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
American society of anesthesiologists defines a difficult airway as the clinical situation in which a trained anesthesiologist has difficulty with face mask ventilation of the upper airway, difficulty with tracheal intubation, or both. Ankylosing spondylitis (AS) can present significant challenges to the anesthetist in view of potentially difficult airway with worsening disease status, namely limitation of movement at the cervical spine and jaw. Associated systemic factors such as pulmonary and cardiovascular complications, along with the risk of iatrogenic cervical spine fractures leading to neurological deterioration adds on to the challenge. However, a careful pre-operative assessment of the overall functional status of the patient along with a comprehensive airway assessment will allow the anesthetist to anticipate and circumvent problems faced intra-operatively, thereby reducing overall morbidity and mortality associated with anesthesia. This study aims to identify systemic and airway parameters associated with the disease that could serve as predictors of an unanticipated difficult airway |