Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06211738 |
| Other study ID # |
APHP240001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 3, 2024 |
| Est. completion date |
February 3, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Maxens DECAVELE, MD |
| Phone |
07.71.27.58.10 |
| Email |
maxens.decavele[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: In Intensive Care Unit (ICU) patients, dyspnea is frequent, severe and exerts
unfavorable effects on the short, medium and long term. Detection and quantification rely on
the patient's self-reporting abilities. However, more than half of the patients in the ICU
are unable to report their sensations. Therefore, the risk is to miss the evaluation of
dyspnea and the potential benefits associated with its control. Observational scales, based
on physiological and behavioral changes related to dyspnea (such as the Mechanical
Ventilation Respiratory Distress Observational Scale MV-RDOS), are promising alternative
tools for the detection of dyspnea in non-communicating patients. However, their routine use
is not standardized, is not supported by any recommendation, but above all, relies largely on
the subjective observation of the facial expression of fear or the abdominal paradox. There
is a need for alternatives to the visual analogue dyspnea scale (D-VAS) for the detection of
dyspnea in non-communicating intubated patients. Analysis of brain cortical activity
modifications during dyspnea could be an alternative to the dyspnea self-report (D-VAS) in
the ICU and could improve the performance of observational dyspnea scales.
Hypothesis: 1) dyspnea during a spontaneous breathing trial (SBT) is associated with premotor
cortex activation identifiable using functional Near-Infrared Spectroscopy (fNIRS); 2)
replacing the items "abdominal paradox" or "facial expression of fear" by HbO2 level could
improve the performance of the MV-RDOS to predict dyspnea in non-communicating intubated
patients; 3) HbO2 level change identified using fNIRS performs well in predicting SBT outcome
Description:
Patient management will not be altered by the study. Patients will be included if the
clinician in charge of the patient has decided to perform a SBT on the patient. SBT
conditions will be those of current practice. The methods used to measure dyspnea will be
those used in current practice in our department (D-VAS and MV-RDOS).
1. Types of measures and techniques used The presence of dyspnea will be defined by a
positive response to at least 2 of the following questions: "Does participant feel short
of breath?"; "Does participant feel short of air?"; "Is participant's breathing
difficult?"; "Does participant have difficulty breathing?". The intensity of dyspnea
will be measured by the D-VAS in communicating patients. The dyspnea-VAS will also
define patients with clinically significant dyspnea ("D-VAS" > 3) or non-clinically
significant dyspnea (D-VAS ≤ 3). Measurement of dyspnea by the MV-RDOS scale will be
performed in all patients, and clinically significant dyspnea will be strongly suspected
by the MV-RDOS value ≥ 2.6.
Surface EMG of the extra-diaphragmatic inspiratory muscles (Alae Nasi and Parasternal)
will be collected via self-adhesive surface electrodes (ECG Electrods, HG91TSG 48x34mm
Kendall/Arbo, Covidien, Dublin, Ireland). 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 placing an
electrode on each nostril. Electrical signals of inspiratory muscle activity will be
retrieved using the Labchart Peak Analysis MLS380/8 module to extract the root mean
square (RMS) of the EMG (RMS-EMG). This envelope of the inspiratory RMS-EMG signal will
be used to calculate the maximum EMG amplitude (EMGmax) and its area under the curve
(EMGAUC). To minimize 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).
Electroencephalographic activity will be measured with an active electrode system
comprising 30 electrodes positioned according to the international EEG 10-20 system,
referenced to Fcz (EEG/NIRS device, Artinis Medical Systems®, Einsteinweg, The
Netherlands). The impedance of the electrodes will be kept below 5 kΩ. The signals will
be amplified and digitized at a frequency of 1000 Hz.
Cerebral perfusion will be assessed using a 27-channel fNIRS tool (EEG/NIRS device,
Artinis Medical Systems®, Einsteinweg, The Netherlands). This fNIRS device uses two
wavelengths of near-infrared light (695 and 830 nm) to measure relative changes in
oxyhemoglobin and deoxyhemoglobin at a sampling rate of 10 Hz. The transmitter and
detector optodes are placed 3 cm apart. The cortical areas between each pair of
transmitters and detectors are called channels. Anatomically, the channels correspond to
the cortical regions located 2-3 cm below the surface of the skin and scalp. The optodes
are placed on the forehead and scalp, with the lowest optodes placed along the T4-Fpz-T3
line, defined by the 10/20 system. The fNIRS signals will be processed as described by
Schecklmann et al. Oxyhemoglobin, deoxyhemoglobin, and total hemoglobin are derived from
the optical densities using the modified Beer-Lambert law. Corrective factors will be
applied to remove motion artifacts. An average oxyhemoglobin and deoxyhemoglobin
waveform will be generated for each channel. The regions of interest being the premotor
cortical areas (supplementary motor area).
SBT failure is defined by the occurrence and persistence for at least 5 minutes of one
of the following criteria: SpO2 (pulsed oxygen saturation) ≤ 90% or PaO2 (partial oxygen
pressure) ≤ 50 mmHg with FiO2 (Inspired oxygen fraction) ≥ 50%, PaCO2 (partial pressure
of carbon dioxide in arterial blood.) > 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 10
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 10-minute period, before the start
of the weaning test, during the 30-minute weaning test and 10 minutes after the end of
the weaning test.
3. Statistical analysis The two groups clinically significant vs. non-clinically
significant dyspnea will be compared on their brain activation indices (HbO2 and HbR)
using the non-parametric Mann-Whitney test for continuous variables and the Chi2 test
for categorical variables. The two SBT "success" vs. "failure" groups will be compared
on their brain activation indices, using the same modalities. The correlations between
their brain activation indices and dyspnea intensity, between their brain activation
indices and EEG, and between their brain activation indices and surface EMG will be
tested using Spearman's correlation coefficient. The performance of the brain activation
indices and the modified MV-RDOS in predicting dyspnea or SBT failure will be estimated
by calculating the area under the curve of ROC curves. An observed difference will be
considered significant if the probability "p" of a type I error is ≤ 0.05.
