Study of influence of ventilatory parameters on the clinical outcome in children on respiratory support (mechanical ventilation).

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/08/056319
• Lead Sponsor: Dr Farhan Shaikh

Brief Summary

•      Children included in the study shall be ventilated on PC mode and sedated as per unit policy.

•      Consent shall be taken

•      Paralysis will be as per unit policy and treating clinician’s discretion

•      The PEEP setting shall be as per the underlying lung condition and treating consultant’s discretion.

•      Setting of Tidal Volume (Vt), PIP, Respiratory Rate (RR), Inspiratory Time (Ti) etc will eb as per the Pediatric Mechanical Ventilation Consensus Conference (PEMVECC)6 guidelines and for pARDS patients as per the PALICC guidelines.

•      The mechanical ventilators used will be GE CARESCAPE R860. Software version 10 (infant Pediatric and adult), Manufacturer: Datex Ohmeda Inc. Made in USA. And MAQUET (GETINGE Group) SERVO-i v8.0 (infant and Pediatric) (Manufacturer. Maquet critical care AB. Sweden).

•      In both GE CARESCAPE R860 and MAQUET Servo-I and Servo-S ventilators, circuit compliance, resistance and leak are measured and compensated each time at the initiation of the ventilation. In both the ventilators the inspiratory tidal volume (VTi) is measured by the inspiratory sensor and displayed on the screen of the ventilators. In both the ventilators the inspiratory flow sensors are automatically zeroed each time when the ventilator is started.

•      Also, whenever possible, using the E –sCOVX module, End Expiratory Lung (EELV) Volume and Functional Residual Capacity (FRC) estimation will be done and strain shall be calculated at 12 hrs and 24-36 hours of ventilation.

In our unit all the ventilators undergo preventive maintenance and calibrations once every year as per the manufacturer recommendations

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-08
• Study Start: 2023-08-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

All patients intubated for respiratory failure and ventilated on Pressure-control mode of ventilation shall be included in the study from 1-month age till 18-years age.

Exclusion Criteria

• Children with neuromuscular diseases, 2.
• Those who got extubated within 24-hours of intubation.
• Those who needed HFOV or ECMO within first 36 hours of admission 4.
• Those who got intubated and ventilated in outside hospitals for more than 12 hours 5.
• Children with immunodeficiency 6.
• Post operative children following Liver or Renal Transplants.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days in a heterogeneous group of mechanically ventilated children	Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days.

Secondary Outcome Measures

Name	Time	Method
calculate Mechanical Power Normalized to body weight (NorMP) and Mechanical Energy and their association with 28-days ventilator free days.	Association with other outcome parameters like PICU length of stay and mortality will be studied.

Trial Locations

Locations (1)

Rainbow Childrens Hospital, road no 2, Bnajara Hills; 🇮🇳 Hyderabad, TELANGANA, India

Rainbow Childrens Hospital, road no 2, Bnajara Hills

🇮🇳Hyderabad, TELANGANA, India

Dr Farhan Shaikh Dr Mounika

Principal investigator

9866007602

farhanshaikh74@gmail.com