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CTRI Number  CTRI/2021/03/031744 [Registered on: 05/03/2021] Trial Registered Prospectively
Last Modified On: 25/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Respiratory muscle training device]  
Study Design  Single Arm Study 
Public Title of Study   Comparison of lung function after inspiratory muscle training in patient with compression of spinal cord in neck. 
Scientific Title of Study   Comparison of pulmonary function after inspiratory muscle training in patients with cervical myelopathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Balabhadra Sai Priyanka  
Designation  MD anaesthesiology junior resident 
Affiliation  Nizams institute of medical sciences 
Address  Department of anesthesia and intensive care 1st floor Old block Nizams institute of medical sciences Punjagutta Hydeerabad

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  saipriyankab@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr padmaja durga 
Designation  professor and HOD 
Affiliation  Nizams institute of medical sciences 
Address  DEPT OF ANAESTHESIA AND INTENSIVE CARE Nizams institute of medical sciences Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9440387299  
Fax    
Email  padmajanims@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Balabhadra Sai Priyanka  
Designation  MD anaesthesiology 3rd year PG 
Affiliation  Nizams institute of medical sciences 
Address  department of anesthesia and intensive care old block 1st floor Nizams institute of medical sciences Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  04023489000  
Fax    
Email  saipriyankab@gmail.com  
 
Source of Monetary or Material Support  
nizams institute of medical sciences punjagutta hyderabad 
 
Primary Sponsor  
Name  Balabhadra Sai Priyanka  
Address  Dept of anesthesiology and intensive care Nizams institute of medical sciences Punjagutta Hyderabad Telangana  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr b sai priyanka  nizams institute of medical sciences  neurosurgery ward 4th floor emergency block And neurosurgery ICU 3RD floor, emergency block
Hyderabad
TELANGANA 
9666851195

saipriyankab@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
nims institute ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G95||Other and unspecified diseases ofspinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  inspiratory muscle training   inspiratory muscle training for 3 days  
Comparator Agent  Pre training Pulmonary function test Post training pulmonary function test  pre-training pulmonary function test immediately after admission Post training pulmonary function test 3 days after inspiratory muscle training and post operative day 1 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients with cervical myelopathy awaiting cervical cord decompressive surgery 
 
ExclusionCriteria 
Details  known case of COPD
KNOWN CASE OF RESPIRATORY INFECTIONS
patient refusal
patients who cannot comprehend the training
patients who cannot sit or requiring immobilization in supine position 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison of change in pulmonary function from pre- training value to post training value  basline value before start of training
comparison value after 3 days of training 
 
Secondary Outcome  
Outcome  TimePoints 
to look for incidence of Post op pulmonary complications  to look for complications for 5 days post operatively 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   10/03/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Patients with cervical spine pathology can have respiratory system dysfunction due to weakness of respiratory muscles including diaphragm or involvement of the respiratory center and lower cranial nerves secondary to medullary compression. Pulmonary aspiration, atelectasis, poor respiratory function, and inadequate cough mechanism secondary to the diaphragm or respiratory muscle involvement can lead to preoperative respiratory abnormalities in patients with cervical spine pathology that might get exaggerated in the postoperative period because of various anesthetic and surgical causes.

Respiratory function is controlled by the phrenic (C3–C5) nerves, the intercostals (T2–10) nerves,  and autonomic nerve, especially the sympathetic (T1–L3) nerves. Therefore, smooth and effective breathing under normal conditions would be impaired by disrupting descending neural pathways at any level in the cervical spine. People with respiratory muscle weakness have a higher risk of PPCs. This is thought to be due to inspiratory muscle fatigue leading to the collapse of alveoli. Even if the impairment of neural function was subclinical, the effect might lead to the deterioration of pulmonary function during the acute postoperative stage. PPCs are comprised of atelectasis, bronchospasm, respiratory failure, pneumonia, and ARDS.

There are several techniques for preoperative respiratory optimization. However, the commonly used IS had been found to have little benefit. IMT can be defined as a technique that aims to improve the function of the inspiratory muscles through specific breathing exercises to increase strength and endurance of the respiratory muscles and therefore improve respiration.   Several authors have reported that preoperative IMT resulted in significant improvement in mean inspiratory muscle strength and endurance after thoracic and abdominal surgery without causing adverse effects.Preoperative IMT has been shown to decrease the incidence of PPCs in patients undergoing cardiac and major abdominal surgery. Thus, it is reasonable to assume that an increase in inspiratory muscle strength and endurance through preoperative IMT can lead to better‐quality deep breathing after surgery, which would in turn result in a decreased incidence of PPCs in patients with cervical myelopathy who have a pre-existing muscle dysfunction.

There are no studies on the role of preoperative muscle training with IMT in patients with cervical myelopathy. In the present study, we have compared pulmonary function after IMT in cervical myelopathy patients and have looked for the incidence of PPCs.

 
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