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Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study

NCT ID: NCT03246425

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-12

Study Completion Date

2017-09-11

Brief Summary

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Mechanical ventilation has been known to produce changes in the flow of blood through the major blood vessels in the body. These changes may go undetected, but with continuous arterial blood pressure measurements, changes in the arterial waveform can be visualized. Although we know that these arterial pressure variations occur during mechanical ventilation, little is known about the effects of various modes of mechanical ventilation on these changes. The most common modes of ventilation used in ICU are Volume control, Pressure control and Airway pressure release ventilation.

Objective We have designed a prospective randomized pilot study to determine the effects of the commonly used ventilator modes on the arterial pressure.

Detailed Description

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Conditions

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Blood Pressure Critical Illness Hypovolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1. Volume control- Pressure control- APRV- VPA group

Group Type ACTIVE_COMPARATOR

Ventilator mode change

Intervention Type OTHER

The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed

Monitoring of blood pressure variation

Intervention Type DEVICE

The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor

2. Pressure control- APRV- Volume control- PAV group

Group Type ACTIVE_COMPARATOR

Ventilator mode change

Intervention Type OTHER

The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed

Monitoring of blood pressure variation

Intervention Type DEVICE

The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor

3. APRV- Volume control- pressure control- AVP group

Group Type ACTIVE_COMPARATOR

Ventilator mode change

Intervention Type OTHER

The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed

Monitoring of blood pressure variation

Intervention Type DEVICE

The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor

Interventions

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Ventilator mode change

The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed

Intervention Type OTHER

Monitoring of blood pressure variation

The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients 18 yrs of age and older, Patients on mechanical ventilation, Patients deeply sedated in the ICU with RASS scores of atleast -3, Patients having an A-line for blood pressure monitoring, Patients with stable hemodynamics.

Exclusion Criteria

Patients with moderate-severe ARDS, Patients requiring high inspiratory oxygen requirements, High peak inspiratory pressures requirement for ventilation, Presence of arrhythmia, Patients with spontaneous breathing activity, Patients on weaning mode, Patients having CHF or Cor pulmonale.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos J Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

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SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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909804-2

Identifier Type: -

Identifier Source: org_study_id