| CTRI Number |
CTRI/2022/03/041373 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Postoperative Respiratory Complications in adult elective neurosurgical population |
|
Scientific Title of Study
|
"Postoperative pulmonary complications in adult elective neurosurgical patients - a prospective observational study." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Salihundam BabyDeepti Chandana |
| Designation |
Senior Resident |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
Department of Neuroanaesthesia,
NIMHANS HOSPITAL,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7032369175 |
| Fax |
|
| Email |
dr.deepti92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Radhakrishnan |
| Designation |
Professor |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
Department of Neuroanaesthesia,
NIMHANS HOSPITAL,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9632589296 |
| Fax |
|
| Email |
mrks1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Salihundam BabyDeepti Chandana |
| Designation |
Senior Resident |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
Department of Neuroanaesthesia,
NIMHANS HOSPITAL,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7032369175 |
| Fax |
|
| Email |
dr.deepti92@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences |
|
|
Primary Sponsor
|
| Name |
Department of NeuroanaesthesiaNIMHANS |
| Address |
NIMHANS Hospital,
Hosur Road,
Bangalore,
Karnataka .
Pin 560029 |
| Type of Sponsor |
Government 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 |
| SBDeepti Chandana |
National Institute of mental health and neurosciences |
Department of Neuroanaesthesia,
NIMHANS Hospital,
Hosur Road,
Bangalore,
Karnataka.
Pin : 560029
Bangalore
KARNATAKA |
7032369175
dr.deepti92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18-75 years
2.Patients undergoing elective neurosurgery, both cranial and spinal surgery requiring
general anaesthesia and controlled mechanical ventilation of the lungs during
surgery |
|
| ExclusionCriteria |
| Details |
patients who are intubated prior to surgery,patient refusal, pregnant women, patients who are not extubated after surgery, patient who underwent General anaesthesia in previous 1 month |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome:
1] To estimate the incidence of PPCs in elective neurosurgical procedures and to determine
the perioperative factors contributing to PPCs. |
1week after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To determine the effect of change in lung ultrasound aeration score on postoperative pulmonary complications 2.to determine the effect of intra operative ventilatory parameters on change in lung ultrasound aeration score and development of postoperative pulmonary complications |
On the day of surgery, postoperative day 1, 1week after Surgery |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
10/04/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this dissertation, adult neurosurgical patients undergoing elective surgeries will be observed to determine the incidence of postoperative pulmonary complications (PPC) in the first seven days of surgery. Clinical examination ,monitoring, chest X ray, ultrasound of thorax will be utilised to detect the occurrence of PPCs. the perioperative factors which lead to PPCs will be identified. Lung ultrasound will be performed to determine lung ultrasound aeration score (LUAS) preoperatively and compared with post operative LUAS to determine its effect on development of PPCs and also to study the effect of ventilator strategies on change in LUAS. |