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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03246425
• Other study ID #: 909804-2
• Status: Withdrawn
• Phase: N/A
• Start date: September 12, 2016
• Est. completion date: September 11, 2017

Study information

• Verified date: August 2017
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 11, 2017
• Est. primary completion date: September 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Critical Illness
• Hypovolemia

Intervention

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

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Stroke Volume variation.		12 months