Cardiac OutputCHARM-ICUNCT05365854
Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers - ICU Patients
A study testing Alveolar Recruitment Maneuver (ARM) in people with Cardiac Output and Hemodynamic Optimization, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The objective of this study was to investigate the hemodynamic effects of two alveolar recruitment maneuver strategies in critical care patients with acute respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Hemodynamic Optimization, Monitoring Blood Pressure
- What is being tested?
- Alveolar Recruitment Maneuver (ARM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patient over 18 years old
- Patient under general anesthesia
- Intubated patient under controlled invasive mechanical ventilation
- Patient with invasive hemodynamic monitoring allowing monitoring of cardiac output and stroke volume
- Patient sufficiently sedated (BIS between 40 and 60) and/or curarized (TOF < 2/4 at the orbicularis) to avoid inspiratory effort
- Patient optimized on the hemodynamic level, in particular with regard to blood volume, following the data from hemodynamic monitoring and the recommendations of the French Society of Anesthesia and Resuscitation (RFE SFAR 2013 - Perioperative Vascular Filling Strategy)
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- Patient covered by a Social Security plan
- Consent of close relatives or trusted person (if present)
- Patient admitted in polyvalent resuscitation within the Peri-Operative Medicine Unit of Clermont-Ferrand hospital suffering from respiratory distress syndrome for less than 24 hours
Who cannot join
- Contraindication to the use of cardiac output measurement by transpulmonary thermodilution
- Cardiac arrhythmia
- Severe valvulopathy
- Contraindication to the use of the Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
- technique
- Left ventricular ejection fraction (LVEF) < 45% and/or right ventricular failure
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- History of pulmonary lobectomy and/or pneumectomy and/or known emphysema
- Patient with restrictive or obstructive lung disease
- Body mass index (BMI) < 16.5 or > 30 kg.m-2
- Pregnancy
- Major under legal protection (guardianship, curators, safeguard of justice)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Clermont-Ferrand, 63000
Thomas Godet, tgodet@chu-clermontferrand.fr
About this study
Official title: Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Intensive Care Unit Patients Under Mechanical Ventilation. A Pilot Physiological Study
The objective of this study was to investigate the hemodynamic effects of two alveolar recruitment maneuver strategies in critical care patients with acute respiratory distress syndrome.
Read the detailed description
Critical care patients are at risk of significant variations in blood volume due to long intervention times, major bleeding or serious pathological conditions, requiring invasive hemodynamic monitoring in routine practice, in order to optimize blood volume and ensure adequate perfusion of the organs, throughout their care.
The installation of an arterial catheter allows continuous monitoring of blood pressure and the realization of blood tests if necessary.
The installation of a central venous line allows the administration of anesthetic drugs and vasopressors as well as an accurate hemodynamic evaluation by transpulmonary thermodilution, which is the most commonly used monitoring in these situations.
After hemodynamic optimization following the monitoring data, the patient will be randomized to one of the two Alveolar Recruitment Maneuver (ARM) order strategies. Mechanical ventilation will be standardized according to current international recommendations (tidal volume between 6 mL.kg-1 and 8 mL.kg-1 of theoretical ideal weight (TIP) for patients with Acute Respiratory Distress Syndrome (ARDS); PEEP equal to 6 cmH2O). Hemodynamic and ventilatory data will be collected (baseline).
The successive realization of the two ARM will then be carried out with collection of the hemodynamic and ventilatory data during the last 10 seconds of each ARM. Between each ARM, conventional ventilation will be resumed for 10 minutes in order to observe a wash-out period, and to allow a return to the baseline state. Data will also be collected as before.
After these measurements have been taken, all management will be left to the discretion of the practitioner caring for the patient.
- Conditions
- Cardiac Output, Hemodynamic Optimization, Monitoring Blood Pressure, Stroke Volume, Mechanical Ventilation, Acute Respiratory Distress Syndrome
- Being tested
- Alveolar Recruitment Maneuver (ARM)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Recruitment Maneuver (ARM)Procedure or surgery
When patient is under general anesthesia, an arterial catheter is placed for cardiac output and stroke volume (SV) monitoring. To avoid pre-load dependency bias, the blood volume will be optimized. A 250mL fluid-challenge of a balanced crystalloid solution is administered under cover of the SV monitoring. If SV variation is greater than 10%, a new fluid-challenge is performed to obtain a reference SV, corresponding to the patient's optimal blood volume.The patient is then "pre-load independent".
Then, patients will be randomized into two groups: a first group will receive a CPAP ARM: 40 cmH2O for 50 seconds, followed by a 10-minute break corresponding to a period of return to basal state; then an extended sigh ARM (e-sigh) also lasting 50seconds (driving pressure: 10cmH2O and successive PEEP levels at 10,15,20,25 and 30cmH2O, a respiratory rate set at 30/min in controlled pressure - 5cycles at each PEEP level); a second group will receive the same two ARM modalities in reverse order.
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure (CPAP) then extended sigh | Active comparator | Patients assigned to this group will receive a CPAP ARM (40cmH2O during 50 seconds), followed by a 10-minute pause corresponding to a period of return to basal state.
Then an ARM by extended sigh (e-sigh) also 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure).
Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver. Receives: Procedure: Alveolar Recruitment Maneuver (ARM) |
| extended sigh then continuous positive airway pressure (CPAP) | Active comparator | Patients assigned to this group will receive an ARM by extended sigh (e-sigh) during 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure), followed by a 10-minute pause corresponding to a period of return to basal state.
Then they receive a CPAP ARM (40cmH2O during 50 seconds). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver. Receives: Procedure: Alveolar Recruitment Maneuver (ARM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the change in cardiac output during the last 10 seconds of each ARM modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed)
Cardiac output (l/min) will be measured by invasive monitoring during the last 10 seconds of each recruitment maneuver
Measured: During procedure (last 10 seconds of each ARM modality)
Secondary outcomes (16)
The secondary outcome measures are the evaluation of standard hemodynamic monitoring data
During the last 10 seconds of the recruitment maneuver, standard hemodynamic monitoring data will be recorded :
blood pressure (mmHg) mean arterial pressure (mmHg)
Measured: During procedure (last 10 seconds of each ARM modality)
Standard hemodynamic monitoring data
heart rate
Measured: During procedure (last 10 seconds of each ARM modality)
Invasive hemodynamic monitoring data
stroke volume (ml/min)
Measured: During procedure (last 10 seconds of each ARM modality)
Invasive hemodynamic monitoring data
change in stroke volume
Measured: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
tidal volume (ml)
Measured: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure,
Measured: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
respiratory rate
Measured: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
inspired oxygen fraction
Measured: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
compliance of the respiratory system
Measured: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
Tidal Impedance Variation (TIV)
Measured: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
Center Of Ventilation (COV) and Global Inhomogeneity index (GI)
Measured: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
Regional Ventilation Delay (RVD)
Measured: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
End Expiratory Lung Impedance (EELI)
Measured: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
percentages of overdistended and atelectasis areas
Measured: During procedure (last 10 seconds of each ARM modality)
The secondary outcome measures are the evaluation of paraclinical data
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Measured: During procedure (last 10 seconds of each ARM modality)
The secondary outcome measures are the evaluation of paraclinical data
During the last 10 seconds of the recruitment maneuver, pulse oxygen saturation (SpO2) will be recorded
Measured: During procedure (last 10 seconds of each ARM modality)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365854
- Sponsor's protocol ID
- RBPH 2021 GODET 3 (Charm ICU)
- Acronym
- CHARM-ICU
- Status last verified
- Feb 2022
- First submitted
- 19 Apr 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Intensive Care Unit Patients Under Mechanical Ventilation. A Pilot Physiological Study
- ClinicalTrials.gov ID
- NCT05365854
- Acronym / sponsor ID
- CHARM-ICU / RBPH 2021 GODET 3 (Charm ICU)
- Conditions
- Cardiac Output, Hemodynamic Optimization, Monitoring Blood Pressure, Stroke Volume, Mechanical Ventilation, Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 9 May 2022 (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.
The objective of this study was to investigate the hemodynamic effects of two alveolar recruitment maneuver strategies in critical care patients with acute respiratory distress syndrome.
Detailed description
Critical care patients are at risk of significant variations in blood volume due to long intervention times, major bleeding or serious pathological conditions, requiring invasive hemodynamic monitoring in routine practice, in order to optimize blood volume and ensure adequate perfusion of the organs, throughout their care.
The installation of an arterial catheter allows continuous monitoring of blood pressure and the realization of blood tests if necessary.
The installation of a central venous line allows the administration of anesthetic drugs and vasopressors as well as an accurate hemodynamic evaluation by transpulmonary thermodilution, which is the most commonly used monitoring in these situations.
After hemodynamic optimization following the monitoring data, the patient will be randomized to one of the two Alveolar Recruitment Maneuver (ARM) order strategies. Mechanical ventilation will be standardized according to current international recommendations (tidal volume between 6 mL.kg-1 and 8 mL.kg-1 of theoretical ideal weight (TIP) for patients with Acute Respiratory Distress Syndrome (ARDS); PEEP equal to 6 cmH2O). Hemodynamic and ventilatory data will be collected (baseline).
The successive realization of the two ARM will then be carried out with collection of the hemodynamic and ventilatory data during the last 10 seconds of each ARM. Between each ARM, conventional ventilation will be resumed for 10 minutes in order to observe a wash-out period, and to allow a return to the baseline state. Data will also be collected as before.
After these measurements have been taken, all management will be left to the discretion of the practitioner caring for the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure (CPAP) then extended sigh | Active comparator | Procedure: Alveolar Recruitment Maneuver (ARM)Patients assigned to this group will receive a CPAP ARM (40cmH2O during 50 seconds), followed by a 10-minute pause corresponding to a period of return to basal state. Then an ARM by extended sigh (e-sigh) also 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver. |
| extended sigh then continuous positive airway pressure (CPAP) | Active comparator | Procedure: Alveolar Recruitment Maneuver (ARM)Patients assigned to this group will receive an ARM by extended sigh (e-sigh) during 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure), followed by a 10-minute pause corresponding to a period of return to basal state. Then they receive a CPAP ARM (40cmH2O during 50 seconds). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient over 18 years old
- Patient under general anesthesia
- Intubated patient under controlled invasive mechanical ventilation
- Patient with invasive hemodynamic monitoring allowing monitoring of cardiac output and stroke volume
- Patient sufficiently sedated (BIS between 40 and 60) and/or curarized (TOF < 2/4 at the orbicularis) to avoid inspiratory effort
Key exclusion criteria (11 listed)
- Contraindication to the use of cardiac output measurement by transpulmonary thermodilution
- Cardiac arrhythmia
- Severe valvulopathy
- Contraindication to the use of the Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
- technique
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 |
|---|---|---|
| Alveolar Recruitment Maneuver (ARM)When patient is under general anesthesia, an arterial catheter is placed for cardiac output and stroke volume (SV) monitoring. To avoid pre-load dependency bias, the blood volume will be optimized. A 250mL fluid-challenge of a balanced crystalloid solution is administered under cover of the SV monitoring. If SV variation is greater than 10%, a new fluid-challenge is performed to obtain a reference SV, corresponding to the patient's optimal blood volume.The patient is then "pre-load independent". Then, patients will be randomized into two groups: a first group will receive a CPAP ARM: 40 cmH2O for 50 seconds, followed by a 10-minute break corresponding to a period of return to basal state; then an extended sigh ARM (e-sigh) also lasting 50seconds (driving pressure: 10cmH2O and successive PEEP levels at 10,15,20,25 and 30cmH2O, a respiratory rate set at 30/min in controlled pressure - 5cycles at each PEEP level); a second group will receive the same two ARM modalities in reverse order. | Procedure or surgery | Continuous positive airway pressure (CPAP) then extended sigh, extended sigh then continuous positive airway pressure (CPAP) |
Primary outcome
The primary outcome measure is the change in cardiac output during the last 10 seconds of each ARM modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed)
Time frame: During procedure (last 10 seconds of each ARM modality)
Cardiac output (l/min) will be measured by invasive monitoring during the last 10 seconds of each recruitment maneuver
16 secondary outcomes
The secondary outcome measures are the evaluation of standard hemodynamic monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard hemodynamic monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Invasive hemodynamic monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Invasive hemodynamic monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
Time frame: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Time frame: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Time frame: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Time frame: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Time frame: During procedure (last 10 seconds of each ARM modality)
Electrical impedance tomography data
Time frame: During procedure (last 10 seconds of each ARM modality)
The secondary outcome measures are the evaluation of paraclinical data
Time frame: During procedure (last 10 seconds of each ARM modality)
The secondary outcome measures are the evaluation of paraclinical data
Time frame: During procedure (last 10 seconds of each ARM modality)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Recruitment Maneuver (ARM) in people with Cardiac Output and Hemodynamic Optimization, run by University Hospital, Clermont-Ferrand 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 473754963, llaclautre_perrier@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the change in cardiac output during the last 10 seconds of each ARM modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed) (time frame: During procedure (last 10 seconds of each ARM modality)). 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 12 May 2022.