Relationship Between Dyspnea and Ventilatory VariabilityDYSREVANCT05762614
Respiratory Variability and Dyspnea During Spontaneous Breathing Trial
An observational study of Relationship Between Dyspnea and Ventilatory Variability, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In intensive care unit, dyspnea, the distressing and fearful awareness of breathing, is frequent and harmful. To be treated, dyspnea must be detected and quantified, which is impossible in approximately 50% of patients receiving invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relationship Between Dyspnea and Ventilatory Variability
- What is being tested?
- Dyspnea assessment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient on invasive mechanical ventilation able to perform a SBT
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Relationship Between Ventilatory Variability and Dyspnea in Patients Under Invasive Mechanical Ventilation During a Weaning Trial
In intensive care unit, dyspnea, the distressing and fearful awareness of breathing, is frequent and harmful. To be treated, dyspnea must be detected and quantified, which is impossible in approximately 50% of patients receiving invasive mechanical ventilation. However, these non-communicative patients are exposed to the same risk factors for dyspnea as communicative patients and the impossibility to communicate a suffering increases its traumatic impact. In addition, simple therapeutic means, such as optimizing the settings of the ventilator, can significantly alleviate or even eliminate dyspnea. It is therefore particularly important to be able to detect and quantify it effectively. The Mechanical Ventilation - Respiratory Distress Observation Scale (MV-RDOS) is an observational dyspnea scale that bypasses patient involvement and represents a promising tool in the detection of dyspnea in non-communicative patients. However, its use is partly based on the observation of the facial expression of fear or the abdominal paradox, the assessment of which remains subjective. The analysis of ventilatory variability, which reflects the load-capacity balance of the respiratory system, could provide an alternative to detect dyspnea in these patients. The investigators are therefore going to measure the ventilatory variability using the thoracic motion signals obtained with a force sensor integrated in a chest strap and the ventilatory flows at airways in patients receiving invasive mechanical ventilation during a spontaneous breathing trial and compare the indices of ventilatory variability with the dyspnea visual analog scale in communicative patients and with the MV-RDOS in all patients (communicative and non-communicative).
Read the detailed description
- 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.
- 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.
- 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.
- Being tested
- Dyspnea assessment
- Keywords
- dyspnea, Ventilatory variability, Weaning, Mechanical ventilation, Intensive care
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyspnea assessmentOther
Dyspnea assessment, respiratory variability, Spirometry, Electromyography
| Study group | Role | What they receive |
|---|---|---|
| patient on invasive mechanical ventilation able to perform a SBT | Not described Receives: Other: Dyspnea assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant dyspnea - D-VAS
Clinically important dyspnea defined by a Dyspnea visual analog scale (D-VAS) > 30 mm for communicating patients
Measured: during SBT
Clinically significant dyspnea - MV-RDOS
Mechanical Ventilation Respiratory Distress Observation Scale(MV-RDOS) ≥ 2.6 for all patients
Measured: during SBT
Secondary outcomes (3)
Intensity of dyspnea
Dyspnea visual analog scale (D-VAS) values or Mechanical Ventilation Respiratory Distress Observation Scale(MV-RDOS) values
Measured: during SBT
issue of the SBT
success or failure of the SBT
Measured: one day
EMG signal
Maximum amplitude and area under the envelope curve of the EMG signal of the extra-diaphragmatic respiratory muscles indicating dyspnoea.
Measured: during SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start12 Apr 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship Between Dyspnea and Ventilatory VariabilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxens Decavele, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762614
- Sponsor's protocol ID
- APHP230055
- Acronym
- DYSREVA
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Ventilatory Variability and Dyspnea in Patients Under Invasive Mechanical Ventilation During a Weaning Trial
- ClinicalTrials.gov ID
- NCT05762614
- Acronym / sponsor ID
- DYSREVA / APHP230055
- Keywords
- dyspnea, Ventilatory variability, Weaning, Mechanical ventilation, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In intensive care unit, dyspnea, the distressing and fearful awareness of breathing, is frequent and harmful. To be treated, dyspnea must be detected and quantified, which is impossible in approximately 50% of patients receiving invasive mechanical ventilation. However, these non-communicative patients are exposed to the same risk factors for dyspnea as communicative patients and the impossibility to communicate a suffering increases its traumatic impact. In addition, simple therapeutic means, such as optimizing the settings of the ventilator, can significantly alleviate or even eliminate dyspnea. It is therefore particularly important to be able to detect and quantify it effectively. The Mechanical Ventilation - Respiratory Distress Observation Scale (MV-RDOS) is an observational dyspnea scale that bypasses patient involvement and represents a promising tool in the detection of dyspnea in non-communicative patients. However, its use is partly based on the observation of the facial expression of fear or the abdominal paradox, the assessment of which remains subjective. The analysis of ventilatory variability, which reflects the load-capacity balance of the respiratory system, could provide an alternative to detect dyspnea in these patients. The investigators are therefore going to measure the ventilatory variability using the thoracic motion signals obtained with a force sensor integrated in a chest strap and the ventilatory flows at airways in patients receiving invasive mechanical ventilation during a spontaneous breathing trial and compare the indices of ventilatory variability with the dyspnea visual analog scale in communicative patients and with the MV-RDOS in all patients (communicative and non-communicative).
Detailed description
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient on invasive mechanical ventilation able to perform a SBT | – | Other: Dyspnea assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient on invasive mechanical ventilation able to perform a SBT
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyspnea assessmentDyspnea assessment, respiratory variability, Spirometry, Electromyography | Other | patient on invasive mechanical ventilation able to perform a SBT |
Primary outcome
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
Clinically significant dyspnea - MV-RDOS
Time frame: during SBT
Mechanical Ventilation Respiratory Distress Observation Scale(MV-RDOS) ≥ 2.6 for all patients
3 secondary outcomes
Intensity of dyspnea
Time frame: during SBT
issue of the SBT
Time frame: one day
EMG signal
Time frame: during SBT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxens Decavele, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relationship Between Dyspnea and Ventilatory Variability, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant dyspnea - D-VAS (time frame: during SBT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.