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

• Conditions: To Assess the Ability of PI to Detect Preload Responsiveness

• Registration Number: NCT06673862
• Lead Sponsor: Benha University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-02
• Last Update Submitted: 2024-11-02
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ability of perfusion index to detect preload responsiveness	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 Outcome Measures

Name	Time	Method
Compare the changes in PI with VTI during a Vt challenge test	Approximately one hour
Compare the changes in VTI and PI during a volume expansion challenge test	Approximately one hour
Compare the Vt-induced changes in PI to changes induced by fluid challenge test	Approximately one hour

Trial Locations

Locations (1)

Faculty of Medicine- Benha University; 🇪🇬 Banhā, Al-Qalyubia, Egypt