NCT06224010

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

2.5 years

First QC Date

January 22, 2024

Last Update Submit

January 23, 2024

Conditions

ARDS, HumanCOVID-19 Respiratory InfectionCOVID-19 Acute Respiratory Distress SyndromeRespiratory Effort-Related ArousalWeaning FailureMechanical Ventilation ComplicationAcute Hypoxic Respiratory Failure

Keywords

ARDSCOVID-19Weaning from mechanical ventilationRespiratory driveInspiratory effortRespiratory monitoring

Outcome Measures

Primary Outcomes (4)

  • Respiratory drive

    Evaluation of respiratory drive using P0.1

    90 breaths

  • Neuroventilatory coupling

    Evaluation of respiratory drive using EAdi PEAK

    90 breaths

  • Respiratory effort

    Evaluation of respiratory drive using ∆Pmus-EAdi derived, ∆Pmus-∆Pocc derived, PTP/min

    90 breaths

  • Transpulmonary driving pressure

    Evaluation of respiratory drive using ∆Plung, dynamic

    90 breaths

Secondary Outcomes (3)

  • Composite outcome

    within forty eight hour from assisted spontaneous breathing

  • Intensive care unit mortality

    Intensive care unit stay

  • Mortality

    60 days after measurement

Study Arms (3)

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)

Other: Respiratory drive and effort assessment

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.

Other: Respiratory drive and effort assessment

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.

Other: Respiratory drive and effort assessment

Interventions

Respiratory drive and effort assessmentOTHER

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-ModerateCOVID-SevereNon-COVID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of acute respiratory distress syndrome due to confirmed (real-time RT-PCR on nasopharyngeal swabs, or lower respiratory tract aspirates) COVID-19 (CARDS), had received invasive mechanical ventilation for more than 72 hours and were candidates for assisted ventilation. The CARDS cohort divided into 'Moderate' and 'Severe' COVID groups according to P/F ratio at ICU admission. A separate cohort of patients with ARDS by etiology different from COVID-19 (No-COVID), enrolled in previous studies and with the same inclusion and exclusion criteria.

You may qualify if:

  • 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:
  • Improvement of the condition leading to acute respiratory failure.
  • Positive end-expiratory pressure lower than 10 cmH2O and inspiratory oxygen fraction lower than 0.5.
  • Richmond agitation sedation scale score between 0 and -3.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.C. Anestesia e Rianimazione 1U A.O.U.- Città della Salute e della Scienza, P.O. Molinette Corso Bramante 88-90

Turin, 10126, Italy

Location

Related Publications (5)

  • Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176.

    PMID: 30389829BACKGROUND

  • Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.

    PMID: 31694692BACKGROUND

  • Di Mussi R, Spadaro S, Mirabella L, Volta CA, Serio G, Staffieri F, Dambrosio M, Cinnella G, Bruno F, Grasso S. Impact of prolonged assisted ventilation on diaphragmatic efficiency: NAVA versus PSV. Crit Care. 2016 Jan 5;20:1. doi: 10.1186/s13054-015-1178-0.

    PMID: 26728475BACKGROUND

  • Di Mussi R, Spadaro S, Volta CA, Bartolomeo N, Trerotoli P, Staffieri F, Pisani L, Iannuzziello R, Dalfino L, Murgolo F, Grasso S. Continuous assessment of neuro-ventilatory drive during 12 h of pressure support ventilation in critically ill patients. Crit Care. 2020 Nov 20;24(1):652. doi: 10.1186/s13054-020-03357-9.

    PMID: 33218354BACKGROUND

  • Vaschetto R, Cammarota G, Colombo D, Longhini F, Grossi F, Giovanniello A, Della Corte F, Navalesi P. Effects of propofol on patient-ventilator synchrony and interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2014 Jan;42(1):74-82. doi: 10.1097/CCM.0b013e31829e53dc.

    PMID: 23982026BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Vito Fanelli, MD, PhD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 25, 2024

Study Start

November 21, 2020

Primary Completion

June 1, 2023

Study Completion

June 20, 2023

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)