- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05762614
Respiratory Variability and Dyspnea During Spontaneous Breathing Trial (DYSREVA)
Analysis of the Relationship Between Ventilatory Variability and Dyspnea in Patients Under Invasive Mechanical Ventilation During a Weaning Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
1. Types of measures and techniques used 1.1. Dyspnea The presence of dyspnea will be defined by a positive response to at least 2 of the following questions: "Do you feel out of breath? " ; "Do you feel a lack of air? " ; "Is your breathing difficult? " ; "Are you having trouble breathing? ". The intensity of dyspnea will be measured by VAS-D in communicative patients. Dyspnea VAS will be used to define patients with clinically significant dyspnea (D-VAS > 30 mm) or non-clinically significant dyspnea (D-VAS ≤ 30 mm). The measurement of dyspnea by the MV-RDOS scale will be performed in all patients and clinically significant dyspnea will be strongly suspected by the value of the MV-RDOS ≥ 2.6.
1.2. Ventilatory variability
The variability will be measured from raw airway flow (reference method) and using a force sensor integrated in a chest strap. The good correlation between the measurement of ventilation by a chest strap and the reference measurement has been demonstrated in healthy volunteers and in obese subjects on all the components of the spirogram: VT, TI, TE, TTOT, VT/TI and TI /TTOT. Two variability indices will be measured:
- The coefficient of variation (CV) of chest expansion, after pre-processing by an artifact elimination algorithm, per period of 5 minutes and displayed continuously as a trend curve on a tablet connected to the sensor
- Frequency analysis of the respiratory signal by Fast Fourier Transformation (FFT) over periods of 5 minutes and calculation of the H1/DC component.
1.3. Surface electromyography of inspiratory extra-diaphragmatic muscles The surface EMG of the extra diaphragmatic inspiratory muscles (Alae Nasi and Parasternals) will be collected via self-adhesive surface electrodes. Bilateral recording of the parasternal muscles will be performed by a pair of electrodes placed in the second intercostal space near the sternum. The recording of the Alae nasi muscles will be performed by positioning an electrode on each nostril. The electrical signals of inspiratory muscle activity will be identified using the Labchart Peak Analysis to extract the root mean square (RMS) of the EMG (RMS-EMG). This envelope of the inspiratory RMS-EMG signal will be used for the calculation of the maximum EMG amplitude (EMGmax) and its area under the curve (EMGAUC). To minimize the artifacts related to ECG activity, the parasternal EMG signal will be filtered before the RMS averaging process, using a low pass filter (50-400 Hz).
1.4. Airway flow and pressure A disposable pneumotachograph and a differential pressure sensor connected to a demodulator will be inserted in series at the proximal end of the breathing circuit between the Y-piece and the patient, allowing measurement of airway flow and pressure.
The signals will be digitized at a sampling frequency of 40 Hz. Ventilatory volumes and times (TI, TE, FR) will be measured from flow rate curves.
4.5. Result of the ventilatory bondage test (SBT) Failure of SBT is defined by the appearance and persistence for at least 5 minutes of one of the following criteria: SpO2 ≤ 90% or PaO2 ≤ 50mmHg with FiO2 ≥ 50%, PaCO2 > 50 mmHg, pH < 7.32, respiratory rate > 35/min, heart rate > 140/min, systolic blood pressure > 180 mmHg or < 90 mmHg.
2. Sequence of experimental steps Patients will be placed in a ventilatory weaning test with 0 cmH2O of pressure support and 0 cmH2O of end-expiratory pressure. A quantification of dyspnea will be performed for all patients using the MV-RDOS score and by Dyspnea VAS (D-VAS) for communicative patients before the start of SBT, every 5 minutes during SBT and at the end of SBT. Recordings of respiratory movements, airway flow, EMG and ECG will be made at the same time, per 5-minute period, 5 minutes before the start of the weaning test and during the 30-minute weaning test.
3. Statistical analyzes Based on a 50% probability of occurrence of clinically significant dyspnea (D-VAS > 30 mm) during the SBT and a decrease in VT CV from 0.25 to 0.18 in case of failure of SBT a total of 86 patients was calculated (alpha risk at 0.05, power 85%, common standard deviation at 0.12), 43 communicative patients and 43 non-communicative. It is therefore planned to include 100 patients in total, including 50 communicative patients and 50 non-communicative patients.
Comparison between the group "clinically significant dyspnea" vs. "not clinically significant" on their variability indices (CV and H1/DC) will be performed using the non-parametric Mann-Whitney test. The two groups "successful" vs. "failure" of the SBT will be compared on their variability indices (CV and H1/DC), according to the same methods. The correlations between variability indices and intensity of dyspnea and between variability indices and surface EMG will be tested using Spearman's correlation coefficient. The performance of the variability indices and the modified MV-RDOS to predict dyspnea or failure of SBT will be estimated by calculating the area under the curve of the ROC curves. An observed difference will be considered significant if the probability "p" of a type I error is ≤ 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Maxens Decavele, MD
- Phone Number: 01.84.82.79.39
- Email: maxens.decavele@aphp.fr
Study Contact Backup
- Name: Alexandre DEMOULE, MD, PhD
- Phone Number: 01.42.16.77.71
- Email: alexandre.demoule@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Hôpital Pitié-Salpétrière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Invasive mechanical ventilation > 48h,
- Readiness-to-wean ability: ability defined by all of the following criteria: effective cough, no excessive tracheo-bronchial secretions, resolution of the disease that prompted the intubation, heart rate ≤ 140/min, pressure systolic blood pressure between 90 and 160 mmHg, no or very low dose of amines, SpO2 > 90% in 40% FiO2 (or PaO2/FiO2 > 150), positive expiratory pressure < 8 cmH2O, respiratory rate ≤ 35/min, tidal volume > 5ml/kg of theoretical body weight, respiratory rate / tidal volume ratio < 105 cycles/min/L
- Decision by the clinician in charge of the patient to perform a SBT,
- Patient or close consent obtained,
- Person affiliated to a Social Security scheme or beneficiary (excluding AME).
Exclusion Criteria:
- Minor patient,
- Pregnant or breastfeeding woman,
- Agitation/sedation: RASS > 2 or < 2,
- Post-operative thoracic or abdominal surgery,
- Chest skin lesion contraindicating the placement of a chest strap,
- Person under legal protection (guardianship, curators), safeguarded by justice.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patient on invasive mechanical ventilation able to perform a SBT
|
Dyspnea assessment, respiratory variability, Spirometry, Electromyography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically significant dyspnea - D-VAS
Time Frame: during SBT
|
Clinically important dyspnea defined by a Dyspnea visual analog scale (D-VAS) > 30 mm for communicating patients
|
during SBT
|
Clinically significant dyspnea - MV-RDOS
Time Frame: during SBT
|
Mechanical Ventilation Respiratory Distress Observation Scale(MV-RDOS) ≥ 2.6 for all patients
|
during SBT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of dyspnea
Time Frame: during SBT
|
Dyspnea visual analog scale (D-VAS) values or Mechanical Ventilation Respiratory Distress Observation Scale(MV-RDOS) values
|
during SBT
|
issue of the SBT
Time Frame: one day
|
success or failure of the SBT
|
one day
|
EMG signal
Time Frame: during SBT
|
Maximum amplitude and area under the envelope curve of the EMG signal of the extra-diaphragmatic respiratory muscles indicating dyspnoea.
|
during SBT
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maxens Decavele, MD, APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP230055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relationship Between Dyspnea and Ventilatory Variability
-
Centre Hospitalier Universitaire VaudoisSwiss National Science FoundationCompletedRelationship Between Calcimimetic and the RAASSwitzerland
-
Christian Ramos PenafielHospital General de Mexico; Universidad Nacional Autonoma de Mexico; Instituto...CompletedEstablish the Relationship Between Moon and BirthsMexico
-
Assiut UniversityRecruitingThe Relationship Between the Anteroposterior Diameter of the CM and the Gestational Age and GenderEgypt
-
Aydin Adnan Menderes UniversityEnrolling by invitationThe Relationship Between TAPSE Value and VolumeTurkey
-
LEO PharmaBayerCompletedRelationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft DevelopmentGermany
-
Mohammed VI University HospitalCompletedthe Relationship Between Procalcitonin and 30-day Mortality in COVID PatientsMorocco
-
Uskudar UniversityCompletedInvestigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic PainTurkey
-
National Taiwan University HospitalRecruitingA Study on the Relationship Between Job Satisfaction and Retention Intentions of Emergency Room NursesTaiwan
-
The First Affiliated Hospital of Guangzhou Medical...Completedthe Relationship Between the Tumor Markers and Interstitial Lung Disease PatientsChina
-
Gulhane School of MedicineCompletedWe Investigated the Relationship Between Plasma FGF23 Levels and Endothelial Dysfunction in a Sizable Series of Incident Stage 3-4 CKD Patients.Turkey
Clinical Trials on Dyspnea assessment
-
Izmir Katip Celebi UniversityCompletedPostural; Defect | COPD | Dyspnea | Respiratory Function ImpairedTurkey
-
CHU de ReimsCompletedMyotonic Dystrophy Type 1 (DM1)France
-
Association pour le Développement et l'Organisation...Completed
-
CHU de ReimsCompleted
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedMetastatic Cancer | Pulmonary ComplicationsUnited States
-
Robert Wood Johnson FoundationCompletedChronic Obstructive Pulmonary DiseaseUnited States
-
Assistance Publique - Hôpitaux de ParisPr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques...CompletedCOPD (With - Without Rehabilitation) | Diffuse Interstitial Lung Diseases | Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....) | Cystic Fibrosis of the AdultFrance
-
CereVu Medical, Inc.John Muir HealthRecruiting
-
Institut für Pneumologie Hagen Ambrock eVActive, not recruitingOSA | COPD | COPD Exacerbation | CHFGermany