Cardiac OutputCHARM-BlocNCT05365113
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients
A study testing alveolar recruitment maneuver in people with Cardiac Output and Decreased Cardiac Output, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The objective of this study is to investigate the hemodynamic effects of two strategies of alveolar recruitment maneuver in patients undergoing major abdominal surgery in the operating room Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Decreased Cardiac Output, Hemodynamic Monitoring
- What is being tested?
- alveolar recruitment maneuver
- 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
- 9 Mar 2022to 31 May 2022
- 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
- patient intubated under controlled invasive mechanical ventilation
- patient with invasive hemodynamic monitoring (transpulmonary thermodilution)
- patient sedated (BIS between 40 and 60) and/or curarized with TOF monitoring to avoid inspiratory effort
- patient optimized on the hemodynamic level, in particular with regard to blood volume, following the hemodynamic monitoring data and the recommendations of the French Society of Anesthesia and Resuscitation (RFE SFAR 2013 - Perioperative vascular filling strategy)
- patient covered by a Social Security plan
- patient consent to participate in the study
Who cannot join
- contraindication to the use of cardiac output measurement
- cardiac arrhythmia
- pace-maker/implantable defibrillator
- severe valvulopathy
- contraindication to the use of the tomographic electroimpedancemetry technique
- thoracic lesions, thoracic dressing
Show all 14Show fewer
- left ventricular ejection fraction (LVEF) < 45% and/or right ventricular failure.
- history of pulmonary lobectomy and/or pneumonectomy and/or known emphysema
- patient with restrictive or obstructive lung disease
- body mass index (BMI) < 16.5 or > 30 kg.m-2
- pregnancy
- intracranial hypertension or suspected intracranial hypertension
- patient under limitation of care
- patient under legal protection (guardianship, curatorship, safeguard of justice)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients: A Physiological Study
The objective of this study is to investigate the hemodynamic effects of two strategies of alveolar recruitment maneuver in patients undergoing major abdominal surgery in the operating room
Read the detailed description
In practice, after induction of general anesthesia and intubation, patients will be conditioned with the recommended monitoring (arterial catheter, central venous catheter, and transpulmonary thermodilution).
Once conditioning is complete, optimization of blood volume will be performed with volumetric expansions (250 mL of Ringer lactate) to achieve a change in stroke volume of less than 10%, as recommended (RFE SFAR 2013 - Perioperative Vascular Filling Strategy). The patient will then be randomized to one of the following groups: [ extended sigh then CPAP ] or [ CPAP then extended sigh ] (random order of ARMs - each patient becoming their own control). In order to homogenize the settings, the mechanical ventilation will be standardized with in particular the use of a PEEP of 6 cmH2O before inclusion and between the ARMs (for a duration of at least 10 minutes in each case).
Hemodynamic values will be recorded during the last 10 seconds of each procedure. Once the two ARMs have been performed, the rest of the management will then be left to the discretion of the practitioner in charge of the patient.
The included patient will be managed according to the recommendations at the time of the study.
- Conditions
- Cardiac Output, Decreased Cardiac Output, Hemodynamic Monitoring, Blood Pressure, Stroke Volume, Major Abdominal Surgery
- Being tested
- alveolar recruitment maneuver
- Keywords
- mechanical ventilation,, hemodynamics,, ARM,, CPAP,, extended sigh,, cardiac output
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitment maneuverProcedure 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 |
| 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 |
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 MRA 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: last 10 seconds of each ARM modality
Secondary outcomes (16)
Standard hemodynamic monitoring data
blood pressure, mean arterial pressure,
Measured: last 10 seconds of each ARM modality
Standard hemodynamic monitoring data
heart rate
Measured: last 10 seconds of each ARM modality
Invasive hemodynamic monitoring data
stroke volume change in stroke volume
Measured: last 10 seconds of each ARM modality
Invasive hemodynamic monitoring data
change in stroke volume
Measured: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
tidal volume (ml)
Measured: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure
Measured: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
respiratory rate,
Measured: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
inspired oxygen fraction,
Measured: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
compliance of the respiratory system
Measured: last 10 seconds of each ARM modality
Electro-impedancemetry data
Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
COV : Center Of Ventilation and GI : Global Inhomogeneity index
Measured: last 10 seconds of each ARM modality
Electro-impedancemetry data
Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
TIV : Tidal Impedance Variation
Measured: last 10 seconds of each ARM modality
Electro-impedancemetry data
Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
RVD : Regional Ventilation Delay
Measured: last 10 seconds of each ARM modality
Electro-impedancemetry data
Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
EELI : End Expiratory Lung Impedance
Measured: last 10 seconds of each ARM modality
Electro-impedancemetry data
Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry 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: last 10 seconds of each ARM modality
Paraclinics data
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Measured: last 10 seconds of each ARM modality
Paraclinics data
During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded
Measured: 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 start9 Mar 2022
- Primary completion31 May 2022
- Study completion31 May 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Exploratory study testing in cross-sectional design two alveolar recruitment maneuvers referenced in practice, in patients under general anesthesia and intubated under controlled ventilation, in operating room
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
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
- NCT05365113
- Sponsor's protocol ID
- RBHP 2021 GODET 4 (Charm Bloc)
- Acronym
- CHARM-Bloc
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. 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 Major Abdominal Surgery Patients: A Physiological Study
- ClinicalTrials.gov ID
- NCT05365113
- Acronym / sponsor ID
- CHARM-Bloc / RBHP 2021 GODET 4 (Charm Bloc)
- Conditions
- Cardiac Output, Decreased Cardiac Output, Hemodynamic Monitoring, Blood Pressure, Stroke Volume, Major Abdominal Surgery
- Keywords
- mechanical ventilation,, hemodynamics,, ARM,, CPAP,, extended sigh,, cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- 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 is to investigate the hemodynamic effects of two strategies of alveolar recruitment maneuver in patients undergoing major abdominal surgery in the operating room
Detailed description
In practice, after induction of general anesthesia and intubation, patients will be conditioned with the recommended monitoring (arterial catheter, central venous catheter, and transpulmonary thermodilution).
Once conditioning is complete, optimization of blood volume will be performed with volumetric expansions (250 mL of Ringer lactate) to achieve a change in stroke volume of less than 10%, as recommended (RFE SFAR 2013 - Perioperative Vascular Filling Strategy). The patient will then be randomized to one of the following groups: [ extended sigh then CPAP ] or [ CPAP then extended sigh ] (random order of ARMs - each patient becoming their own control). In order to homogenize the settings, the mechanical ventilation will be standardized with in particular the use of a PEEP of 6 cmH2O before inclusion and between the ARMs (for a duration of at least 10 minutes in each case).
Hemodynamic values will be recorded during the last 10 seconds of each procedure. Once the two ARMs have been performed, the rest of the management will then be left to the discretion of the practitioner in charge of the patient.
The included patient will be managed according to the recommendations at the time of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Exploratory study testing in cross-sectional design two alveolar recruitment maneuvers referenced in practice, in patients under general anesthesia and intubated under controlled ventilation, in operating room
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure (CPAP) then extended sigh | Active comparator | Procedure: alveolar recruitment maneuverPatients 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 maneuverPatients 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 (8 listed)
- patient over 18 years old
- patient under general anesthesia
- patient intubated under controlled invasive mechanical ventilation
- patient with invasive hemodynamic monitoring (transpulmonary thermodilution)
- patient sedated (BIS between 40 and 60) and/or curarized with TOF monitoring to avoid inspiratory effort
Key exclusion criteria (14 listed)
- contraindication to the use of cardiac output measurement
- cardiac arrhythmia
- pace-maker/implantable defibrillator
- severe valvulopathy
- contraindication to the use of the tomographic electroimpedancemetry 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 maneuverWhen 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 MRA modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed)
Time frame: 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
Standard hemodynamic monitoring data
Time frame: last 10 seconds of each ARM modality
Standard hemodynamic monitoring data
Time frame: last 10 seconds of each ARM modality
Invasive hemodynamic monitoring data
Time frame: last 10 seconds of each ARM modality
Invasive hemodynamic monitoring data
Time frame: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
Time frame: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
Time frame: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
Time frame: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
Time frame: last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data
Time frame: last 10 seconds of each ARM modality
Electro-impedancemetry data
Time frame: last 10 seconds of each ARM modality
Electro-impedancemetry data
Time frame: last 10 seconds of each ARM modality
Electro-impedancemetry data
Time frame: last 10 seconds of each ARM modality
Electro-impedancemetry data
Time frame: last 10 seconds of each ARM modality
Electro-impedancemetry data
Time frame: last 10 seconds of each ARM modality
Paraclinics data
Time frame: last 10 seconds of each ARM modality
Paraclinics data
Time frame: last 10 seconds of each ARM modality
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 18 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Cardiac Output and Decreased Cardiac Output, 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 8 inclusion and 14 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 18 Jun 2023. 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?
The primary outcome measure is the change in cardiac output during the last 10 seconds of each MRA modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed) (time frame: 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 18 Jun 2023.