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

Study Overview
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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.

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

Conditions
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Blood Pressure, Critical Illness, Hypovolemia

Intervention / Treatment
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* Other: Ventilator mode change
* Device: Monitoring of blood pressure variation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Volume control- Pressure control- APRV- VPA group<br> | Other: Ventilator mode change<br>* 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<br>Device: Monitoring of blood pressure variation<br>* The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor<br>|
| Active Comparator: 2. Pressure control- APRV- Volume control- PAV group<br> | Other: Ventilator mode change<br>* 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<br>Device: Monitoring of blood pressure variation<br>* The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor<br>|
| Active Comparator: 3. APRV- Volume control- pressure control- AVP group<br> | Other: Ventilator mode change<br>* 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<br>Device: Monitoring of blood pressure variation<br>* The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Stroke Volume Variation. |  | For 12 months | 
| The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Pulse Pressure Variation |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Pulse Pressure Variation |  | For 12 months | 
| Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Stroke Volume variation. |  | 12 months |