Trial of Total Lung Protective Ventilation in Adult VV-ECMO Patients With Severe ARDS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
The purpose of this study is to find a better way to protect the lungs of patients with Acute Respiratory Distress Syndrome (ARDS) who are being treated with a mechanical ventilator in addition to an extracorporeal membrane oxygenation (ECMO) machine. ARDS is a serious lung condition that makes it hard to breathe. People with ARDS often need care in the intensive care unit (ICU) and can become very sick with high mortality rates despite optimal care.
Doctors usually support patients with through ARDS with a breathing machine called a ventilator. The ventilator helps lungs imitate taking small breaths to help protect the lungs from more damage, however ventilator induced lung injury (VILI) can still contribute significantly to organ injury.
For patients in whom a ventilator is not enough support due to the severity of their lung disease, veno-venous (VV) ECMO can fully support the lungs while they recover. In these sickest patients, it is important to avoid causing more lung damage with the ventilator. Protecting the lungs may help them heal faster and may also help protect other parts of the body. More people are now being treated with VV ECMO, but there is still not enough research to know which ventilator settings are safest and work best. Most current recommendations are based on doctors' experience instead of research studies. This study will help researchers learn the best way to use ventilators for patients on VV ECMO and improve their recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
On VV ECMO for less than 24 hours at time of study consent
Acute onset: Within 1 week of known clinical insult
Bilateral infiltrates: Evidence of fluid/inflammation in both lungs on X-ray, CT, or US, not fully explained by cardiac failure or fluid overload
Origin of Edema: Respiratory failure not fully explained by cardiac failure or fluid overload
Disqualifiers
Have received ECMO for >24 hours
Are on VV ECMO but are not mechanically ventilated, or are planned not to have/not require invasive mechanical ventilation for >24 hours
Patient is pregnant
Patient is a prisoner
Trial design
Design model
Parallel
Treatments tested in this trial
Mechanical Power Targeted Ventilation
Procedure/SurgeryFor patients assigned to the intervention arm, the patient will be placed on volume control (VC) or pressure control (PC) ventilation with either an initial tidal volume of 3-4cc/kg predicted body weight (PBW) (for VC) or inspiratory pressure required to reach the same tidal volume goal (for PC), FiO2 set between 0.30-0.50, and PEEP of at least 10. This tidal volume or inspiratory pressure, for VC and PC respectively, will then be titrated down to meet a goal plateau pressure of less than or equal to 24 cmH2O, and a target driving pressure no greater than 14 cmH2O. Finally, the respiratory rate will then be titrated between 1 and 15 to meet the specified mechanical power goal range. Once the respiratory rate has been lowered to 8, tidal volumes will be lowered to 3cc/kg PBW prior to further reductions in respiratory rate. Mechanical power (MP) will be calculated every two hours and adjusted as needed to stay within the goal MP range until pre-defined weaning criteria are met.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Routine CareNo intervention 0 interventions
Group B: Targeted InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of prospective, randomized mechanical power-based strategy to establish a causal relationship between MP and clinical outcomes.
The primary outcome is to assess the feasibility of the intervention protocol, as assessed by the number of patients adhering to mechanical power (MP) protocol, with a target adherence of \>/= 90% of the intervention time spent within the assigned mechanical power range.
Time frame
From enrollment to the end of the intervention window of 7 days.Secondary outcomes
1
To evaluate the safety of a total lung protective ventilation strategy utilizing a mechanical power targeted strategy versus conventional ultra-low tidal volume ventilation.
Secondary outcome one: safety, as measured by the incidence of refractory hypoxemia and/or hypercarbia occurring during intervention window as defined by a sustained PaO2 of \<50 mmHg or saturation \<85% on two arterial blood gases drawn \>30 minutes apart and for hypercarbia as sustained PaCO2 \>65 mmHg with associated respiratory acidosis noted by a pH \< 7.20 on two arterial blood gases drawn \>30 minutes apart. Reported as number of patients in whom either incidence occurred at least one time during intervention window.
Time frame
From enrollment to end of intervention window of 7 days2
To evaluate the tolerability of a total lung protective ventilation strategy utilizing a mechanical power targeted strategy versus conventional ultra-low tidal volume ventilation.
Second outcome measure: Tolerability; as measured by sedative requirements as assessed by daily the Richmond Agitation-Sedation Scale (RASS) ranging from -5 to +4 with lower scores indicating a need for deeper sedation and less tolerability. Reported as median numerical score with interquartile range (IQR).
Time frame
From enrollment to end of intervention window of 7 days3
To evaluate the tolerability of a total lung protective ventilation strategy utilizing a mechanical power targeted strategy versus conventional ultra-low tidal volume ventilation.
Second outcome measure: Tolerability; as measured by requirement for use of continuous neuromuscular blockade. Reported as median number of days with interquartile ranges for which a patient requires continuous neuromuscular blockade for greater than four hours. A lower median number of days receiving continuous neuromuscular blockade indicates greater tolerability.
Time frame
From enrollment to end of intervention window of 7 daysOther outcomes
1
Surfactant Protein D (SP-D)
Additional exploratory outcome: Biomarkers; This will include the impact on physiologic markers of VILI via serial measurements of plasma biomarker: Surfactant Protein D, reported in pg/mL from days 0-7.
Time frame
From enrollment to end of intervention window at day 7.2
Duration of ECMO Support
Additional outcomes: ECMO; This will include the duration of ECMO support as reported by ECMO free days by day 60.
Time frame
From enrollment to end of study participation (post hospitalization visit 12 weeks after discharge.)3
Mortality
Additional outcome: Mortality; incidence of mortality as reported by incidence at by day 60.
Time frame
From enrollment to end of study participation (post hospitalization visit 12 weeks after discharge.)4
Organ Failure Free Days
Additional outcome: Organ Failure; as reported by the number of organ failure-free days by day 28 defined as: absence of vasopressor support (cardiovascular), absence of invasive or noninvasive (HFNC or NIPPV) respiratory support (pulmonary), and absence of renal replacement therapy (renal) and reported as median number of days with interquartile ranges.
Time frame
From enrollment to end of study participation (post hospitalization visit 12 weeks after discharge.)Sponsors and contacts
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Source ClinicalTrials.gov
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