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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  
Name  Address 
 
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  
Status 
Not Applicable 
 
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
 
 
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.

 
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