The study investigates if a brief breath volume change in a ventilator-induced patient can indicate fluid therapy response by detecting pulse pressure changes in severe breathing patients receiving breaths through machines and in a prone position.

Change in PPV with Tidal Volume Challenge to assess fluid responsiveness in patients suffering from Acute Respiratory Distress Syndrome undergoing low tidal volume mechanical ventilation in prone position - Nil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063146

Enrollment

Registered

2024-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J960- Acute respiratory failure Health Condition 2: 4- Measurement and Monitoring

Interventions

Intervention1: tidal volume challenge: The tidal volume challenge will be performed by increasing Vt to 8 mL/kg PBW, and pulse contour cardiac index, PPV, and SVV will be recorded after 1 minute and c

Eligibility

Inclusion criteria

Inclusion criteria: 1 Adult patients Age more than 18 years 2 Suffering From Acute Respiratory Distress Syndrome ARDS defined as per Berlins Criteria. 3 Undergoing mechanical ventilation via lung protective low tidal volume strategy using Volume assist control ventilation without any spontaneous breathing activity (deeply sedated/ paralyzed as seen on pressure time curve on ventilator), in prone position. 4 Having invasive continuous cardiac output monitoring using PICCO device (Pulsion Medical Systems, Feldkirchen, Germany) with Phillips Intel View monitor MP700 5 Patients of acute circulatory failure defined as the presence of systolic blood pressure (SBP) less than or equal to 90 mm Hg or mean arterial pressure (MAP) less than or equal to 70 mm Hg or requiring vasopressors to maintain SBP more than 90 or MAP more than 70 along with one or more of the following: a) urine flow less than 0.5 mL per kg per hr for more than 2hours. b) heart rate more than 100 beats per minute. c) Presence of skin mottling d) blood lactate concentration more 2 mmol per L in whom the treating physician plans to give a fluid bolus

Exclusion criteria

Exclusion criteria: 1 Age less than 18 years. 2 Patients with cardiac arrythmia, known valvular heart disease, intracardiac shunt, right ventricular dysfunction, air leakage through chest drains, abdominal compartment syndrome. 3 Pregnant Females 4 Patient refusing consent to participate in the study 5 Extravascular Lung water Index (EVLWI) >12 (except in those patients in whom treating clinician wishes to give a fluid bolus to the patient)

Design outcomes

Secondary

Measure	Time frame
To study the effect of lung compliance on the validity of tidal volume challenge test to predict fluid responsiveness in patients suffering from ARDS undergoing low tidal volume ventilation in prone ventilation.Timepoint: 1 months after starting the trial enrollment	—

Primary

Measure	Time frame
To assess whether change in PPV while transiently increasing tidal volume to 8ml per kg Predicted Body Weight in patients suffering from ARDS undergoing low tidal volume ventilation in prone position adequately predicts fluid responsiveness.Timepoint: 30 min after starting the intervention	—

Countries

India

Contacts

Public ContactMasood Ali Mujawar

Tata Memorial Hospital, Mumbai

sheila150@hotmail.com9820156070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026