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

• Sponsor: State University of New York - Upstate Medical University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03246425
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure; Critical Illness; Hypovolemia	Other: Ventilator mode change; Device: Monitoring of blood pressure variation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study
• Actual Study Start Date: Sep 12, 2016
• Actual Primary Completion Date: Sep 11, 2017
• Actual Study Completion Date: Sep 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1. Volume control- Pressure control- APRV- VPA group	Other: 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; Device: 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
Active Comparator: 2. Pressure control- APRV- Volume control- PAV group	Other: 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; Device: 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
Active Comparator: 3. APRV- Volume control- pressure control- AVP group	Other: 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; Device: 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

Outcome Measures

Primary Outcome Measures

1. 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]

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 Pulse Pressure Variation [12 Months]

Secondary Outcome Measures

1. Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Pulse Pressure Variation [For 12 months]

2. Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Stroke Volume variation. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUNY Upstate Medical University	Syracuse	New York	United States	13210

Sponsors and Collaborators

• State University of New York - Upstate Medical University

Investigators

• Principal Investigator: Carlos J Lopez, MD, State University of New York - Upstate Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: State University of New York - Upstate Medical University
• ClinicalTrials.gov Identifier: NCT03246425
• Other Study ID Numbers: 909804-2
• First Posted: Aug 11, 2017
• Last Update Posted: Oct 22, 2021
• Last Verified: Aug 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Critical Illness; Hypovolemia

Study Results

No Results Posted as of Oct 22, 2021