Stroke Volume VariationHemorecrutNCT03215329
Comparison of Hemodynamic Effect of 2 Methods for Alveolar Recruitment Maneuver in Anesthetized Patients
An observational study of Stroke Volume Variation and Arterial Pressure, run by University Hospital, Caen at 1 site in France.
Trial summary
During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar recruitment manoeuvres (ARM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Volume Variation, Arterial Pressure
- What is being tested?
- abdominal or vascular surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2017to 31 Dec 2017
- 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: adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor
Who may be able to join
- adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor
Who cannot join
- Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction < 30%, or preoperative pulmonary disease
Trial locations and contacts
1 site in 1 country.
Jean-Luc Hanouz, M.D,Ph.D contact
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen, 14000
Jean-Luc Hanouz, M.D.,Ph.D., hanouz-jl@chu-caen.fr
About this study
Official title: Comparison of Stroke Volume Variation During Alveolar Recruitment With Stepwise Increase in Positive End Expiratory Pressure and Continuous Positive Airway Pressure (30cmH2O During 30 Seconds) in Anesthetised Patients
During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient increase in intrathoracic pressure during ARMs decreases venous return and increases pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by hypovolemia, heart failure, and in patients with chronic treatment wich impedes cardiovascular responses to hypovolemia. At our best knowledge, there is no study which compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP. Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM methods in anesthetized patients.
Read the detailed description
This is a single-centre prospective observational study performed in operating rooms of the university hospital of Caen.
Inclusion criteria were adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the european guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction < 30%, or preoperative pulmonary disease were excluded.
After intravenous line placement and monitoring (IntelliVue MP70 Philips HealthCare, Amsterdam, The Netherlands) with continuous 5-lead electrocardiography, pulse oximetry, and bispectral index, after local anaesthesia a radial intra-arterial catheter was inserted and connected to a pressure transducer zeroed at the intersection of the mid axillary line and the fifth intercostal space. Arterial pressure and pulse pressure variation (PPV) were continuously displayed on the IntelliVue MP70 monitor. After a 3 to 5 min preoxygenation, anaesthesia was induced and maintained using target-controlled total intravenous anaesthesia with propofol and remifentanil. If a neuromuscular blocking agent was administered its effect was monitored by accelerometry at the thumb following Train-of-Four stimulations of the ulnar nerve repeated every 30 seconds. Following orotracheal intubation; patients were ventilated with controlled ventilation mode (inspired Oxygen fraction 40%, tidal volume: 8ml.kg-1, PEEP at +5 to +8 cmH2O, inspiratory to expiratory ratio of ½, respiratory rate between 10 and 15 min-1 to maintain an end-tidal carbon dioxide partial pressure of 30 to 35 mmHg). An oesophageal Doppler probe connected to its monitor was inserted after tracheal intubation (CardioQ-ODM, Deltex Medical, UK). Then, a fluid challenge was performed with 250 ml of colloid or crystalloid at the discretion of anaesthesiologist and repeated if the SV increased by more than 10%.
The first ARM was performed after orotracheal intubation and SV optimisation. Two preset ARM were available on the anaesthesia respirator: CPAP at 30 cmH2O for 30 seconds (CPAP30) and a stepwise increase and decrease in PEEP (PEEPsteps). The choice of the ARM was left at the discretion of the attending anaesthesiologist.
Heart rate, arterial pressure (systolic, diastolic, mean), PPV, pulse oximetry, cardiac index (CI), SV, peak velocity (PV), corrected flow time (FTc, averaged across 10 successive measurements), and bispectral index were recorded by an independent observer before the ARM, during the ARM at the nadir of SV variation, and 1 (after1) and 3 (after3) min after the end of the ARM.
Definitions of outcomes The primary outcome was the absolute variation of SV during ARM. The secondary outcomes were: variation of arterial blood pressure (mean, systolic and diastolic), PPV, CI, PV, FTc, and pulse oximetry
- Conditions
- Stroke Volume Variation, Arterial Pressure
- Being tested
- abdominal or vascular surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal or vascular surgeryProcedure or surgery
Intermediate or high risk abdominal or vascular surgery
| Study group | Role | What they receive |
|---|---|---|
| CPAP30 | Alveolar recruitment maneuver with a continuous positive airway pressure (CPAP) at 30 cmH2O during 30 seconds Receives: Procedure: abdominal or vascular surgery | |
| PEEPsteps | Alveolar recruitment maneuver with a stepwise increase and decrease in positive end expiratory pressure from 5 to 20 cmH2O. Receives: Procedure: abdominal or vascular surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in stroke volume
stroke volume measured by transoesophageal doppler probe
Measured: before and during the alveolar recruitment maneuver
Secondary outcomes (6)
cardiac index
cardiac index measured by transoesophageal doppler probe
Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver
pulse pressure variation
pulse pressure variation displayed on the hemodynamic monitor
Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver
arterial pressure
arterial pressure : systolic, diastolic and mean
Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver
heart rate
heart rate displayed on the hemodynamic monitor
Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver
peak velocity
peak velocity measured by transoesophageal doppler probe
Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver
Corrected Flow Time
Corrected Flow Time measured by transoesophageal doppler probe
Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start2 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Volume VariationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Hanouz, M.D,Ph.D, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215329
- Sponsor's protocol ID
- A15-D27-VOL.25
- Acronym
- Hemorecrut
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stroke Volume Variation During Alveolar Recruitment With Stepwise Increase in Positive End Expiratory Pressure and Continuous Positive Airway Pressure (30cmH2O During 30 Seconds) in Anesthetised Patients
- ClinicalTrials.gov ID
- NCT03215329
- Acronym / sponsor ID
- Hemorecrut / A15-D27-VOL.25
- Conditions
- Stroke Volume Variation, Arterial Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 12 Jul 2017 (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.
During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient increase in intrathoracic pressure during ARMs decreases venous return and increases pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by hypovolemia, heart failure, and in patients with chronic treatment wich impedes cardiovascular responses to hypovolemia. At our best knowledge, there is no study which compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP. Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM methods in anesthetized patients.
Detailed description
This is a single-centre prospective observational study performed in operating rooms of the university hospital of Caen.
Inclusion criteria were adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the european guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction < 30%, or preoperative pulmonary disease were excluded.
After intravenous line placement and monitoring (IntelliVue MP70 Philips HealthCare, Amsterdam, The Netherlands) with continuous 5-lead electrocardiography, pulse oximetry, and bispectral index, after local anaesthesia a radial intra-arterial catheter was inserted and connected to a pressure transducer zeroed at the intersection of the mid axillary line and the fifth intercostal space. Arterial pressure and pulse pressure variation (PPV) were continuously displayed on the IntelliVue MP70 monitor. After a 3 to 5 min preoxygenation, anaesthesia was induced and maintained using target-controlled total intravenous anaesthesia with propofol and remifentanil. If a neuromuscular blocking agent was administered its effect was monitored by accelerometry at the thumb following Train-of-Four stimulations of the ulnar nerve repeated every 30 seconds. Following orotracheal intubation; patients were ventilated with controlled ventilation mode (inspired Oxygen fraction 40%, tidal volume: 8ml.kg-1, PEEP at +5 to +8 cmH2O, inspiratory to expiratory ratio of ½, respiratory rate between 10 and 15 min-1 to maintain an end-tidal carbon dioxide partial pressure of 30 to 35 mmHg). An oesophageal Doppler probe connected to its monitor was inserted after tracheal intubation (CardioQ-ODM, Deltex Medical, UK). Then, a fluid challenge was performed with 250 ml of colloid or crystalloid at the discretion of anaesthesiologist and repeated if the SV increased by more than 10%.
The first ARM was performed after orotracheal intubation and SV optimisation. Two preset ARM were available on the anaesthesia respirator: CPAP at 30 cmH2O for 30 seconds (CPAP30) and a stepwise increase and decrease in PEEP (PEEPsteps). The choice of the ARM was left at the discretion of the attending anaesthesiologist.
Heart rate, arterial pressure (systolic, diastolic, mean), PPV, pulse oximetry, cardiac index (CI), SV, peak velocity (PV), corrected flow time (FTc, averaged across 10 successive measurements), and bispectral index were recorded by an independent observer before the ARM, during the ARM at the nadir of SV variation, and 1 (after1) and 3 (after3) min after the end of the ARM.
Definitions of outcomes The primary outcome was the absolute variation of SV during ARM. The secondary outcomes were: variation of arterial blood pressure (mean, systolic and diastolic), PPV, CI, PV, FTc, and pulse oximetry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP30 | – | Procedure: abdominal or vascular surgeryAlveolar recruitment maneuver with a continuous positive airway pressure (CPAP) at 30 cmH2O during 30 seconds |
| PEEPsteps | – | Procedure: abdominal or vascular surgeryAlveolar recruitment maneuver with a stepwise increase and decrease in positive end expiratory pressure from 5 to 20 cmH2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor
Key inclusion criteria (1 listed)
- adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor
Key exclusion criteria (1 listed)
- Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction < 30%, or preoperative pulmonary disease
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 |
|---|---|---|
| abdominal or vascular surgeryIntermediate or high risk abdominal or vascular surgery | Procedure or surgery | CPAP30, PEEPsteps |
Primary outcome
change in stroke volume
Time frame: before and during the alveolar recruitment maneuver
stroke volume measured by transoesophageal doppler probe
6 secondary outcomes
cardiac index
Time frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
pulse pressure variation
Time frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
arterial pressure
Time frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
heart rate
Time frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
peak velocity
Time frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
Corrected Flow Time
Time frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Jean-Luc Hanouz, M.D,Ph.D contact
Jean-Luc Hanouz, M.D,Ph.D principal investigator
University Hospital, Caen
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 Stroke Volume Variation and Arterial Pressure, run by University Hospital, Caen 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 1 inclusion and 1 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 Jul 2017. 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 Jean-Luc Hanouz, M.D,Ph.D (hanouz-jl@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in stroke volume (time frame: before and during the alveolar recruitment maneuver). 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 Jul 2017.