Stress Index to Individualize Mechanical Ventilation in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02871102
• Other study ID #: 160770
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU-free days to 14 days after enrollment	Comparison of ICU-free days to 14 days after enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.	14 days post-enrollment
Other	Ventilator-free days to 14 days after enrollment	Comparison of ventilator-free days to 14 days after enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.	14 days post-enrollment
Other	ICU mortality at 28 days	Comparison of 28-day ICU mortality post-enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.	28 days post-enrollment
Other	In-hospital mortality at 28 days	Comparison of 28-day in-hospital mortality post-enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.	28 days post-enrollment
Other	Time-varying elastance	Assessment of the stability of a model-imputed estimate of time-varying elastance for a given insufflation volume independent of total tidal volume per breath.	Completion of the study intervention, less than 1 day
Other	Comparison of ARDSnet-optimized and time-varying elastance-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 the point of rise of model-imputed time-varying elastance at ARDSnet PEEP on experimental protocol.	Completion of the study intervention, less than 1 day
Other	Comparison of ARDSnet-optimized and time-varying elastance-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 time-varying elastance not rising.	Completion of the study intervention, less than 1 day
Other	Comparison of ARDSnet-optimized and time-varying elastance-optimized PEEP	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 without a rising time-varying elastance) versus the PEEP established by ARDSnet table.	Completion of the study intervention, less than 1 day
Primary	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
Primary	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	Comparison of ARDSnet-optimized and protocol-optimized PEEP	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.	Completion of the study intervention, less than 1 day
Secondary	Comparison of ARDSnet-optimized and protocol-optimized elastance	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.	Completion of the study intervention, less than 1 day