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Enrolling by Invitation

NCT Number: NCT06673862

Changes in Pulse-Oximetry Perfusion Index Induced by Tidal Volume Challenge Versus Fluid Volume Challenge to Detect Preload Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume

The primary goal of this study was to assess the ability of PI changes induced by a Vt challenge or fluid challenge test to detect preload responsiveness in critically ill adult patients on mechanical ventilation with low-tidal volume.

The secondary aims were (i) to compare the changes in PI with VTI during a Vt challenge test (ii) to compare the changes in VTI and PI during a volume expansion challenge test, (iii) to compare the Vt-induced changes in PI to changes induced by fluid challenge test, (iv) to compare the Vt-induced changes in VTI to changes induced by fluid challenge test.

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Key information

Conditions

To Assess the Ability of PI to Detect Preload Responsiveness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine- Benha University

Banhā, Al-Qalyubia, 13518, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients of both genders aged 18 years or older Invasive mechanical ventilation in assist controlled mode with a Vt of 6 mL/kg PBW, Patients with circulatory failure Decision by the clinicians in charge to assess preload responsiveness through a Vt Challenge and a Fluid Challenge test.

Patients in sinus rhythm

Exclusion criteria

Open chest Pulmonary hypertension Poor lung compliance (Crs <30 ml/cmH2O) Obesity (BMI≥35) Pregnancy Intraabdominal hypertension Prone position Atrial fibrillation

Treatment and study plan

Primary outcomes

  1. The ability of perfusion index to detect preload responsiveness

    Time frame: Approximately one hour

    The primary goal of this study was to assess the ability of PI changes induced by a Vt challenge or fluid challenge test to detect preload responsiveness in critically ill adult patients on mechanical ventilation with low-tidal volume.

Secondary outcomes

  1. Compare the changes in PI with VTI during a Vt challenge test

    Time frame: Approximately one hour

  2. Compare the changes in VTI and PI during a volume expansion challenge test

    Time frame: Approximately one hour

  3. Compare the Vt-induced changes in PI to changes induced by fluid challenge test

    Time frame: Approximately one hour

Other outcomes

  1. Compare the Vt-induced changes in VTI to changes induced by fluid challenge test

    Time frame: Approximately one hour

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Changes in Pulse-Oximetry Perfusion Index Induced by Tidal Volume Challenge Versus Fluid Volume Challenge to Detect Preload Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.