CClinicalTrials.gg
WithdrawnNCT03246425Updated Oct 22, 2021

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

An interventional study of Ventilator mode change and Monitoring of blood pressure variation in Blood Pressure, Critical Illness and Hypovolemia, sponsored by State University of New York - Upstate Medical University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2016, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Pressure
  • Critical Illness
  • Hypovolemia
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

Browse Critical Illness studies →

Lead sponsor

State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1. Volume control- Pressure control- APRV- VPA group

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

  • Active comparator
    2. Pressure control- APRV- Volume control- PAV group

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

  • Active comparator
    3. APRV- Volume control- pressure control- AVP group

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

Interventions

  • OtherVentilator 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

  • DeviceMonitoring 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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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

    Time frame: 12 Months

Secondary outcomes

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

    Time frame: 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.

    Time frame: 12 months

07

Study locations

1 site
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03246425
Lead sponsor
State University of New York - Upstate Medical University
Responsible party
Sponsor
First posted
Aug 11, 2017
Start date
Sep 12, 2016
Primary completion
Sep 11, 2017
Completion
Sep 11, 2017
Last update
Oct 22, 2021

Study contacts

Carlos J Lopez, MD
principal investigator · State University of New York - Upstate Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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