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

November 2, 2024 updated by: Salwa Abbas Awad Eltahawy, Benha University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al-Qalyubia
      • Banhā, Al-Qalyubia, Egypt, 13518
        • Faculty of Medicine- Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted on 75 mechanically ventilated patients with circulatory failure.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately one hour

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Compare the Vt-induced changes in VTI to changes induced by fluid challenge test
Time Frame: Approximately one hour
Approximately one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Ahmed Mostafa Abdelhamid, Benha University
  • Principal Investigator: Samar Rafik Mohamed Amin, Benha University
  • Principal Investigator: Mona Sobhy Emara, Benha University
  • Principal Investigator: Salwa Abbas Awad Eltahawy, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

November 2, 2024

First Submitted That Met QC Criteria

November 2, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MD 2-8-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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