Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-21

Study Completion Date

2023-06-20

Brief Summary

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Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation

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Detailed Description

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Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 \<100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation.

The main ventilatory pattern variables:

* Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion.
* Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements.
* Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure .
* Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration.
* Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc\*0.75)
* Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 \* ∆Pocc
* Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm.
* Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity.
* Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath.
* Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation.
* Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles.
* Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration.
* Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration.
* Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath.
* Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator.
* Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration.
* Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration.

Conditions

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ARDS, Human COVID-19 Respiratory Infection COVID-19 Acute Respiratory Distress Syndrome Respiratory Effort-Related Arousal Weaning Failure Mechanical Ventilation Complication Acute Hypoxic Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-COVID

* This group includes patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) caused by etiologies other than COVID-19.
* ARDS was defined following Berlin criteria (2012)

Respiratory drive and effort assessment

Intervention Type OTHER

The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients

COVID-Moderate

* Moderate COVID indicates a less severe level of hypoxemia compared to the Severe COVID group (according to Berlin criteria).
* The moderate COVID group is further characterized by a diagnosis of moderate Acute Respiratory Distress Syndrome (ARDS), based on a P/F ratio (partial pressure of oxygen/fraction of inspired oxygen) at ICU admission.
* The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique.
* RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA.

Respiratory drive and effort assessment

Intervention Type OTHER

The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients

COVID-Severe

* The severe COVID group has a diagnosis of Acute Respiratory Distress Syndrome (ARDS)
* The severity of COVID-19 in this group is determined by a P/F ratio at ICU admission, indicating a higher level of hypoxemia and a more critical clinical condition.
* The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique.
* RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA.

Respiratory drive and effort assessment

Intervention Type OTHER

The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients

Interventions

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Respiratory drive and effort assessment

The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of acute respiratory distress syndrome based on the Berlin criteria.
* Patients with ARDS due to confirmed COVID-19 through real-time RT-PCR on nasopharyngeal swabs or lower respiratory tract aspirates.
* Patients who had received invasive mechanical ventilation for more than 72 hours.
* Patients who were candidates for assisted ventilation.

Readiness for assisted ventilation, which was defined by the following criteria:

1. Improvement of the condition leading to acute respiratory failure.
2. Positive end-expiratory pressure lower than 10 cmH2O and inspiratory oxygen fraction lower than 0.5.
3. Richmond agitation sedation scale score between 0 and -3.
4. Ability to trigger the ventilator, i.e., decrease pressure airway opening by more than 3-4 cmH2O during a brief (5-10 seconds) end-expiratory occlusion test.

* Hemodynamic stability without vasopressor or inotropes, except for dobutamine and norepinephrine infusion below certain thresholds (dobutamine \<5 gamma/Kg/min and norepinephrine \<0.3 gamma/Kg/min).
* Normothermia.

Exclusion Criteria

* Patients affected by neurological or neuromuscular pathology and/or known phrenic nerve dysfunction.
* Patients with any contraindication to the insertion of a nasogastric tube, such as recent upper gastrointestinal surgery or esophageal varices.
* Patients \< 18 years old

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No