| CTRI Number |
CTRI/2018/10/016021 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
28/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effects of low values set on a breath delivering machine and time taken to take off the support from machine |
|
Scientific Title of Study
|
Pressure Support As A Weaning Mode In Neonates: 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 |
Aathira Rajan |
| Designation |
MSc Respiratory Therapy |
| Affiliation |
KMC , Manipal |
| Address |
Dept of Respiratory Therapy
School of Allied Health Sciences(SOAHS)
KMC Manipal
Kasturba Medical College
Madhav Nagar
Manipal, Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9663908238 |
| Fax |
|
| Email |
aathirarajan1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Leslie Lewis |
| Designation |
Professor of Pediatrics |
| Affiliation |
Department of Pediatrics |
| Address |
Kasturba Medical College
Madhav Nagar
Manipal, Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9663908238 |
| Fax |
|
| Email |
leslielewis1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aathira Rajan |
| Designation |
MSc Respiratory Therapy |
| Affiliation |
KMC , Manipal |
| Address |
Dept of Respiratory Therapy
School of Allied Health Sciences(SOAHS)
KMC Manipal
Kasturba Medical College
Madhav Nagar
Manipal, Karnataka
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9663908238 |
| Fax |
|
| Email |
aathirarajan1995@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aathira Rajan |
| Address |
Department of Respiratory Therapy,SOAHS,MAHE,Manipal |
| 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 |
| Aathira Rajan |
Kasturba hospital |
Madhav Nagar, Opp. Tiger Circle ,Manipal. Neonatal ICU
Udupi
Dakshina Kannada
KARNATAKA |
9663908238
-
aathirarajan1995@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Katurba college and kasturba hospital institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All newborn infants 26-37 weeks requiring mechanical ventilation |
|
| ExclusionCriteria |
| Details |
newborns with congenital heart disease, air leak syndrome , hemodynamic instability and without inform consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of time between weaning and early extubation |
duration of time between weaning and early extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requiring reintubation within 48 hours
Mean airway pressure on PSV and SIMV
Air leak
Use of HFOV mode |
Reintubation within 48 hours and other parameters throughout the ICU course |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2018 |
| Date of Study Completion (India) |
13/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/04/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
All newborns from 26- 37 weeks of gestation requiring mechanical ventilation admitted at the NICU. Neonates will be recruited from the time of initiation of ventilation. The initial mode of ventilation was SIMV and once they are ready to wean, the mode was switched over to PSV Hemodynamic and ventilator parameters will be recorded throughout the PSV trial at two-time points of which one was at the initiation of PSV and another at thirty minutes of PSV. On PSV mode vitals signs( heart rate, respiratory rate, SpO2)and ventilator parameters ( Pressure support, FiO2, PEEP, flow, mean airway pressure,tidal volume, compliance) and calculated parameters( respiratory severity score and C20/C,Sp02 /FiO2 ratio)were recorded during PSV trial and once the neonates were ready, they were extubated and put on non invasive mode of ventilation. A total of 22 neonates were enrolled for the study during the time period. Set parameters measured parameters and calculated parameters were recorded during thirty minutes PSV trial. We did not observe any changes in hemodynamic, set or measured ventilator parameters throughout the trial and the incidence of reintubation was found to be five of which two reintubated within 72 hours due to severe hypoxemia and three after 72hours due to inadequate secretion clearance and severe bleeding associated with surgery. Mean airway pressure (MAP) among PSV and SIMV mode was also analyzed, MAP was found to be less in PSV mode with p <0.0001 which could be explained because of the less pressure used during PSV rather than in SIMV mode ,on which mean airway could have been influenced by inspiratory time, pressure control and set respiratory rate. Since there were no observed hemodynamic instability or any deterioration in ventilation at the end of thirty minutes of PSV, explained by stable ventilation not requiring any increase in ventilatory parameters to achieve the target indicate the safety of PSV mode in neonates as an independent mode. Thus it is concluded that PSV can be used in neonates with proper monitoring. |