Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: To Assess the Ability of PI to Detect Preload Responsiveness
Keywords: fluid responsiveness
VTI
PI
tidal volume challenge
fluid challenge
perfusion index
velocity time index
preload responsiveness
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted on 75 mechanically ventilated patients with circulatory failure.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The ability of perfusion index to detect preload responsiveness
timeFrame: Approximately one hour
Secondary outcomes:
measure: Compare the changes in PI with VTI during a Vt challenge test
timeFrame: Approximately one hour
measure: Compare the changes in VTI and PI during a volume expansion challenge test
timeFrame: Approximately one hour
measure: Compare the Vt-induced changes in PI to changes induced by fluid challenge test
timeFrame: Approximately one hour
Other outcomes:
measure: Compare the Vt-induced changes in VTI to changes induced by fluid challenge test
timeFrame: Approximately one hour
Locations:
city: Banhā
country: Egypt
facility: Faculty of Medicine- Benha University
state: Al-Qalyubia
Study officials:
affiliation: Benha University
name: Ahmed Mostafa Abdelhamid
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Samar Rafik Mohamed Amin
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Mona Sobhy Emara
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Salwa Abbas Awad Eltahawy
role: PRINCIPAL_INVESTIGATOR
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