| CTRI Number |
CTRI/2024/05/067803 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the respiratory muscle capacity using ultrasound in patients undergoing surgery in spine of neck region |
|
Scientific Title of Study
|
Point of care ultrasound (POCUS) to detect diaphragmatic dysfunction in adult patients undergoing cervical spine 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.Bhargavi Vallabhaneni |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical college |
| Address |
Department of Neuroanaesthesia, 6th floor
Christian medical college Vellore,
Kilminnal Village, Ranipet,Tamilnadu, India
Vellore TAMIL NADU 632517 India |
| Phone |
9493533545 |
| Fax |
|
| Email |
bhargavi.vallabhaneni@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Karen Lionel Jacob |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical college |
| Address |
Department of Neuroanaesthesia, 6th floor
Christian medical college, Vellore,
Kilminnal Village, Ranipet
Vellore TAMIL NADU 632517 India |
| Phone |
9493533545 |
| Fax |
|
| Email |
karen@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr.Bhargavi Vallabhaneni |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical college |
| Address |
Department of Neuroanaesthesia, 6th floor
Christian Medical college Vellore, Kilminnal Village, Ranipet
Vellore TAMIL NADU 632517 India |
| Phone |
9493533545 |
| Fax |
|
| Email |
bhargavi.vallabhaneni@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christain medical college, vellore, Tamil Nadu, India, 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Vellore,Tamilnadu India - 632004 |
| Type of Sponsor |
Private 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 Bhargavi vallabhaneni |
Christian medical college,vellore, India |
Neurosurgery theatre, CMC ranipet campus Vellore TAMIL NADU |
9493533545
bhargavi.vallabhaneni@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Christian medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, (2) ICD-10 Condition: M471||Other spondylosis with myelopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
i. Adults aged ≥18 years
ii. Cervical spine surgery: Laminectomy, corpectomy, discectomy, cervical spine fusion surgery for degenerative/traumatic indications, cervical spinal tumours (extradural, intradural extramedullary and intramedullary)
iii. Surgery for Craniovertebral junction anomalies
iv. Cervical spine trauma requiring surgery
v. ASA 1, 2 and 3
|
|
| ExclusionCriteria |
| Details |
i.Patient refusal
ii. Patients on mechanical ventilation in the preoperative period.
iii. Patients with low Glasgow coma scale (less than 8) and unable to obey commands.
iv. Patients with preexisting medical conditions causing respiratory dysfunction, including but not limited to Guillain Barre syndrome, motor neuron diseases, and bulbar poliomyelitis.
v.Prior history of cardiothoracic surgery
vi. Recent upper abdominal surgery in the past six weeks
vii. ASA 4 and 5
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of patients diagnosed to have diaphragmatic dysfunction by point-of-care ultrasound preoperatively and at 72 hours after surgery
|
preoperative baseline
and postoperative 72 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Postoperative respiratory complications like respiratory failure, respiratory infections, respiratory distress, the requirement for non-invasive ventilation, reintubation, and prolonged mechanical ventilation within 30 days of discharge
2. Need for postoperative oxygen supplementation for more than 6 hrs.
3. Association of preoperative functional clinical myelopathy grades like modified Indian Nurick grade and Modified JOA with diaphragmatic dysfunction
|
till hospital discharge
and 30 days within discharge |
|
|
Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
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)
|
01/06/2024 |
| 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) |
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
|
Introduction Perioperative diaphragmatic dysfunction is often an incidental diagnosis. It is most commonly reported in high-level traumatic cervical spinal cord injury patients where the cervical spinal cord ischemia is the cause and also in cardiothoracic surgeries where the aetiology is phrenic nerve injury. It is not well studied in chronic cervical myelopathies and cranio-vertebral junction anomalies, where both these mechanisms can cause diaphragmatic dysfunction. Diaphragmatic ultrasound is a bedside, user-friendly and non-invasive method to detect diaphragmatic dysfunction routinely used in critical settings to predict weaning failure in critically ill patients. In our study, we plan to screen for diaphragmatic dysfunction in all adult patients undergoing cervical spine surgery in the perioperative period with the help of diaphragmatic ultrasound. We also plan to study its association with preoperative respiratory function, clinical myelopathy grading and postoperative respiratory complications. Purpose In our study, we plan to look at the prevalence of diaphragmatic dysfunction in the population undergoing cervical spine surgery in our hospital. Our primary objective is to identify those with diaphragmatic dysfunction in the perioperative period. Secondarily, we plan to examine the association between patients’ functional status, including their functional grading, bedside pulmonary function tests, and diaphragmatic dysfunction on the ultrasound. We hope to identify risk factors for postoperative respiratory complications in these patients. This study aims to identify patients at risk for diaphragmatic dysfunction and plan perioperative management and optimisation strategies in these patients. Study design: Prospective, observational study. |