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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

hanouz-jl@chu-caen.fr

France1 site, 1 recruiting
  • CHU de Caen

    Caen, 14000

    Jean-Luc Hanouz, M.D.,Ph.D., hanouz-jl@chu-caen.fr

    Recruiting

Other trials in France

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

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 groups in NCT03215329
Study groupRoleWhat they receive
CPAP30Alveolar recruitment maneuver with a continuous positive airway pressure (CPAP) at 30 cmH2O during 30 seconds
Receives: Procedure: abdominal or vascular surgery
PEEPstepsAlveolar 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.

  1. change in stroke volume

    stroke volume measured by transoesophageal doppler probe

    Measured: before and during the alveolar recruitment maneuver

Secondary outcomes (6)
  1. cardiac index

    cardiac index measured by transoesophageal doppler probe

    Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver

  2. pulse pressure variation

    pulse pressure variation displayed on the hemodynamic monitor

    Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver

  3. arterial pressure

    arterial pressure : systolic, diastolic and mean

    Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver

  4. heart rate

    heart rate displayed on the hemodynamic monitor

    Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver

  5. peak velocity

    peak velocity measured by transoesophageal doppler probe

    Measured: before, during, 1 and 3 min after the alveolar recruitment maneuver

  6. 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.

  1. First posted12 Jul 2017
  2. Study start2 Jan 2017
  3. Primary completion31 Dec 2017 (estimated)
  4. Study completion31 Dec 2017 (estimated)

Resources

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)
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

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.

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