Stress Index to Individualize Mechanical Ventilation in ARDS

Not Applicable

Terminated

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: Recruitment Maneuver with PEEP and Tidal Volume Optimization

• Registration Number: NCT02871102
• Lead Sponsor: Vanderbilt University

Brief Summary

Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP). Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible means to minimize ventilator-induced lung injury. This protocol aims to identify the range of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-18
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Admitted to the Intensive Care Unit
• Receiving invasive mechanical ventilation via endotracheal or tracheostomy tube
• Presence of ARDS by Berlin Criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a PaO2/FiO2 of <300 or SpO2/FiO2 <315)

Exclusion Criteria

• Inability to obtain surrogate consent

• Presence of specified comorbidities:

  1. pregnancy
  2. pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented < 1L or baseline hypercapnia
  3. cerebral edema
  4. known intra-cranial abnormality
  5. acute coronary syndrome

• Endotracheal or tracheostomy cuff leak

• Chest tube with persistent air leak

• Severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations)

• Presence of spontaneous respiratory activity as evidenced by examination of the ventilator waveform tracing

• Intrinsic PEEP of > 5 cmH2O

• Assessment of study staff or patient's attending physician that the patient would not be a good study participant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Recruitment Maneuver with PEEP and Tidal Volume Optimization	-

Primary Outcome Measures

Name	Time	Method
Comparison of ARDSnet-optimized and protocol-optimized tidal volume	Completion of the study intervention, less than 1 day	Mean absolute difference between tidal volume in cc/kg PBW prescribed by ARDSnet settings on ARDSnet PEEP versus maximal protective tidal volume defined by stress index \<1.05 at the ARDSnet PEEP on experimental protocol.
Comparison of ARDSnet-optimized and protocol-optimized driving pressure	Completion of the study intervention, less than 1 day	Mean difference in driving pressure prescribed by ARDSnet settings versus at lowest measured possible driving pressure that achieves equivalent minute ventilation as ARDSnet table with respiratory rate \< or = 35 per minute and SI \<1.05.

Secondary Outcome Measures

Name	Time	Method
Comparison of ARDSnet-optimized and protocol-optimized PEEP	Completion of the study intervention, less than 1 day	Mean absolute difference between safest PEEP as determined by experimental protocol with tidal volume of 6 mL/kg PBW (defined as the PEEP at which 6 mL/kg PBW yields the lowest driving pressure with a SI \<1.05) versus the PEEP established by ARDSnet table.
Comparison of ARDSnet-optimized and protocol-optimized elastance	Completion of the study intervention, less than 1 day	Mean difference in elastance prescribed by ARDSnet settings versus at lowest measured possible elastance achieving equivalent minute ventilation as ARDSnet table with respiratory rate \< or = 35 per minute.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States