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

NCT03246425 | Withdrawn FDA Device

• 1 other identifier: 909804-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure; Critical Illness; Hypovolemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

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

ACTIVE COMPARATOR

Other: Ventilator mode change; Device: Monitoring of blood pressure variation

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

ACTIVE COMPARATOR

Other: Ventilator mode change; Device: Monitoring of blood pressure variation

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

ACTIVE COMPARATOR

Other: Ventilator mode change; Device: Monitoring of blood pressure variation

Interventions

Ventilator mode change 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

1. Volume control- Pressure control- APRV- VPA group; 2. Pressure control- APRV- Volume control- PAV group; 3. APRV- Volume control- pressure control- AVP group

Monitoring of blood pressure variation 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

1. Volume control- Pressure control- APRV- VPA group; 2. Pressure control- APRV- Volume control- PAV group; 3. APRV- Volume control- pressure control- AVP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Critical Illness; Hypovolemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos J Lopez, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: August 11, 2017
• Study Start: September 12, 2016
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2017
• Last Updated: October 22, 2021

Record last verified: 2017-08

Locations

US (1)