| 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
|
|
|
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
|
|
|
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 betterâ€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.
|