Stress Index to Individualize Mechanical Ventilation in ARDS

NCT02871102 | Terminated DMC

• 1 other identifier: 160770
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

mechanical ventilation; respiratory mechanics; acute respiratory distress syndrome; positive end-expiratory pressure; tidal volume

Outcome Measures

Primary Outcomes (2)

• Comparison of ARDSnet-optimized and protocol-optimized tidal volume

  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.

  Completion of the study intervention, less than 1 day

• Comparison of ARDSnet-optimized and protocol-optimized driving pressure

  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.

  Completion of the study intervention, less than 1 day

Secondary Outcomes (2)

• Comparison of ARDSnet-optimized and protocol-optimized PEEP

  Completion of the study intervention, less than 1 day

• Comparison of ARDSnet-optimized and protocol-optimized elastance

  Completion of the study intervention, less than 1 day

Other Outcomes (8)

• ICU-free days to 14 days after enrollment

  14 days post-enrollment

• Ventilator-free days to 14 days after enrollment

  14 days post-enrollment

• ICU mortality at 28 days

  28 days post-enrollment

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Procedure: Recruitment Maneuver with PEEP and Tidal Volume Optimization

Interventions

Recruitment Maneuver with PEEP and Tidal Volume Optimization PROCEDURE

A staircase recruitment maneuver will be performed on pressure control ventilation followed by a decremental PEEP trial. During the decremental PEEP trial inspiratory tidal volumes will be varied at each step between 3 ml/kg and 10 ml/kg predicted body weight while recording the continuous pressure and flow tracings from the mechanical ventilator. With each PEEP and tidal volume combination, end expiratory and end-inspiratory plateau pressure and stress index will be assessed. At the completion of the decremental PEEP trial, the patient will be returned to ARDSnet-recommended ventilator settings.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Inability to obtain surrogate consent
• Presence of specified comorbidities:
• pregnancy
• pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented \< 1L or baseline hypercapnia
• cerebral edema
• known intra-cranial abnormality
• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• McKown AC, Semler MW, Rice TW. Best PEEP trials are dependent on tidal volume. Crit Care. 2018 May 2;22(1):115. doi: 10.1186/s13054-018-2047-4.

  PMID: 29720277 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

US (1)