Predicting Fluid Responsiveness Using Transiently Increased Intrathoracic Pressure in Mechanically Ventilated Patients

NCT03413657 | Completed

• 1 other identifier: 1086731
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to identify in patients requiring active fluid resuscitation and mechanical ventilation for circulatory shock, can a controlled increase in intrathoracic pressure (either by positive-end expiratory pressure (PEEP) or tidal volume (TV)) predict responsiveness to additional fluid resuscitation. We hypothesize that a temporary, physiologically-safe increase in positive-end expiratory pressure (PEEP) and/or a temporary increase in tidal volume (from 6 cc/kg predicted body weight (PBW) to 8 cc/kg PBW) in patients requiring invasive mechanical ventilation will predict fluid responsiveness based upon an assessment of the change in pulse pressure and stroke volume variation.

Conditions

Fluid Reponsiveness

Outcome Measures

Primary Outcomes (1)

• Pulse Pressure Variation

  Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an absolute increase in pulse pressure variation by 3% or more.

  Following 60 seconds of intrathoracic pressure challenge

Secondary Outcomes (5)

• Heart Rate

  Following 60 seconds of intrathoracic pressure challenge

• Mean Arterial Pressure

  Following 60 seconds of intrathoracic pressure challenge

• Mortality

  7 days

• Stroke Volume Variation

  Following 60 seconds of intrathoracic pressure challenge

• End-tidal carbon dioxide

  Following 60 seconds of intrathoracic pressure challenge

Study Arms (2)

Fluid responders

OTHER

Patient's identified to have a significant increase in their cardiac output following a fluid bolus.

Procedure: Increase in intrathoracic pressure

Fluid non-responders

OTHER

Patient's identified to NOT have a significant increase in their cardiac output following a fluid bolus.

Procedure: Increase in intrathoracic pressure

Interventions

Increase in intrathoracic pressure PROCEDURE

Will transiently increase intrathoracic pressure for 60 seconds and monitor for changes in hemodynamics during this time.

Also known as: PEEP Challenge, Tidal Volume Challenge

Fluid non-responders; Fluid responders

Eligibility Criteria

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

You may qualify if:

• Mechanically ventilated
• Identified by treatment team as requiring intravenous fluid bolus
• Acute circulatory failure during admission (systolic blood pressure (SBP) ≤90 mmHg or mean arterial pressure (MAP) ≤70 mmHg or requiring vasopressors to maintain SBP \>90 mmHg or MAP \>70 mmHg, along with one or more of the following:
• urinary flow ≤0.5 mL/kg/min for ≥2 hours,
• heart rate ≥100 beats per minute
• presence of skin mottling
• blood lactate concentration ≥4 mmol/L

You may not qualify if:

• Contraindication to fluid bolus
• Assynchrony Index \> 10%
• Clinically significant cardiac arrhythmia
• Severe valvular heart disease
• Chest tubes with air leak
• Abdominal compartment syndrome
• Pregnancy
• Concurrent nebulized medication or inhaled nitric oxide
• Transthoracic echogenicity unsuitable for measuring velocity-time integral of aortic blood flow (SVI)
• Prisoner
• Clinical brain death
• PEEP \> 15 cmH2O

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Study Officials

• John Adams, MD

  Attending Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either undergo the PEEP challenge or tidal volume challenge first. After the initial challenge, subjects will cross over to whichever challenge has not yet been performed. Subjects will be separated into the following categories: "fluid responders" and "non-responders" and analyzed in those categories.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 29, 2018
• Study Start: December 27, 2017
• Primary Completion: September 13, 2018
• Study Completion: September 13, 2018
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)