Stress Index to Individualize Mechanical Ventilation in ARDS

NCT ID: NCT02871102

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Group Type: EXPERIMENTAL

Recruitment Maneuver with PEEP and Tidal Volume Optimization

Intervention Type: 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.

Interventions

Recruitment Maneuver with PEEP and Tidal Volume Optimization

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 Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Andrew McKown

Fellow in Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29720277 (View on PubMed)

Other Identifiers

160770

Identifier Type: -

Identifier Source: org_study_id