AnesthesiaNCT03910179
Dynamic Arterial Elastance During General Anesthesia Induction
An observational study of Anesthesia, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2019to Apr 2021
- 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: Patients undergone to general anesthesia for surgery that need mini-invasive cardiac output monitoring.
Who may be able to join
- Patients that will be undergone to general anesthesia for surgery
- Patients that need mini-invasive cardiac output monitoring during surgery
Who cannot join
- Age <18 yo
- Pregnancy
- Arrhythmia
- Severe valvular diseases
- Uncorrectable alterations of arterial signal
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliero Universitaria Ospedali Riuniti Ancona
Ancona
Abele Donati, MD, PhD, +390715964603, a.donati@univpm.it
About this study
Official title: Dynamic Arterial Elastance as Predictive Parameter of Hypotension During General Anesthesia Induction.
This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.
Read the detailed description
As general anesthetics may be responsible for vasodilation and cardiac depression, arterial hypotension after induction of general anesthesia is a common event and may contribute to an adverse outcome. Dynamic arterial elastance has been proposed as a functional parameter of arterial tone and studies showed that it was able to predict pressure response to fluid administration in fluid-responsive patients and the amount of mean arterial pressure riduction as a conseguence of noradrenaline dose reduction in critically ill patients.
- Conditions
- Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline value of Eadyn as predictor of hypotension occurrence due to general anesthesia induction
Dynamic arterial elastance (Eadyn) will be recorded at baseline before induction of general anesthesia. Mean arterial pressure (MAP) will be recorded at baseline and continuously until tracheal intubation. The lowest value of MAP will be considered to define hypotension occurrence.
Measured: From baseline (before general anesthesia induction) up to 30 minutes.
Secondary outcomes (1)
Correlation between Eadyn and severity of hypotension due to anesthesia induction
To evaluate the correlation between the baseline value of Eadyn and the severity of hypotension when it will occur after induction of general anesthesia
Measured: From baseline (before general anesthesia induction) up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start10 Sep 2019
- Primary completionJul 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, MD, PhD, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910179
- Sponsor's protocol ID
- CLRIA-AC01
- Status last verified
- Mar 2020
- First submitted
- 4 Apr 2019
- Last updated
- 25 Mar 2020
- 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 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Arterial Elastance as Predictive Parameter of Hypotension During General Anesthesia Induction.
- ClinicalTrials.gov ID
- NCT03910179
- Acronym / sponsor ID
- CLRIA-AC01
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 10 Apr 2019 (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.
This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.
Detailed description
As general anesthetics may be responsible for vasodilation and cardiac depression, arterial hypotension after induction of general anesthesia is a common event and may contribute to an adverse outcome. Dynamic arterial elastance has been proposed as a functional parameter of arterial tone and studies showed that it was able to predict pressure response to fluid administration in fluid-responsive patients and the amount of mean arterial pressure riduction as a conseguence of noradrenaline dose reduction in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone to general anesthesia for surgery that need mini-invasive cardiac output monitoring.
Key inclusion criteria (2 listed)
- Patients that will be undergone to general anesthesia for surgery
- Patients that need mini-invasive cardiac output monitoring during surgery
Key exclusion criteria (5 listed)
- Age <18 yo
- Pregnancy
- Arrhythmia
- Severe valvular diseases
- Uncorrectable alterations of arterial signal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline value of Eadyn as predictor of hypotension occurrence due to general anesthesia induction
Time frame: From baseline (before general anesthesia induction) up to 30 minutes.
Dynamic arterial elastance (Eadyn) will be recorded at baseline before induction of general anesthesia. Mean arterial pressure (MAP) will be recorded at baseline and continuously until tracheal intubation. The lowest value of MAP will be considered to define hypotension occurrence.
1 secondary outcome
Correlation between Eadyn and severity of hypotension due to anesthesia induction
Time frame: From baseline (before general anesthesia induction) up to 30 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
Related trials for Anesthesia
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness
Consciousness, Level Altered
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.
Azienda ospedaliero Universitaria Ospedali Riuniti Ancona
Ancona, Italy
Abele Donati, MD, PhD principal investigator
Università Politecnica delle Marche
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 Anesthesia, run by Università Politecnica delle Marche at 1 site in Italy.
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 2 inclusion and 5 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 25 Mar 2020. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline value of Eadyn as predictor of hypotension occurrence due to general anesthesia induction (time frame: From baseline (before general anesthesia induction) up to 30 minutes.). 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 25 Mar 2020.