HemodynamicsNCT04131699
Electrical Velocimetry (ICON Cardiometry ) Assessment of Hemodynamic Changes During Pediatric Thoracoscopic Surgery
An observational study of Hemodynamics, run by Cairo University at 1 site in Egypt.
Trial summary
Advances in endoscopic equipment and technique have led to the use of minimally invasive thoracic surgery in an increasing number of pediatric surgical procedures. Logically, thoracoscopic surgery and anesthesia can induce significant physiologic changes,, derangements of normal respiratory physiology induced by the… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Cardiotronic ICON continuous non-invasive cardiac output monitor.
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 5 Jan 2020
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: infants and neonates who are a candidate for thoracoscopic surgeries, and suffer no congenital heart disease.
Who may be able to join
- ASA physical status I-II.
- Age neonates and infants
- Children undergoing thoracoscopic surgery surgeries.
Who cannot join
- Parents' or guardians' refusal.
- Left lateral positioning
- Congenital heart diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Velocimetry (ICON Cardiometry) Assessment of Hemodynamic Changes With Different Inflation Pressures During Pediatric Thoracoscopic Surgery: A Pilot Study
Advances in endoscopic equipment and technique have led to the use of minimally invasive thoracic surgery in an increasing number of pediatric surgical procedures. Logically, thoracoscopic surgery and anesthesia can induce significant physiologic changes,, derangements of normal respiratory physiology induced by the surgical approach and the installation of carbon dioxide into the thoracic cavity can lead to alterations of normal acid-base status. Finally, surgical procedures in the chest, surgical traction or insufflation pressures impairs venous return and/or cardiac function, especially in neonates and infants. In this study Electrical Cardiometry TM (ICON, Cardiotronic/Osypka Medical, Inc., La Jolla CA, USA) is used assess the effect of different intra-thoracic pressure (insufflation pressures 4,5 \& 6 mmHg) during thoracoscopic surgeries in neonates and infants on hemodynamics using electrical velocimetry (ICON) as non-invasive monitoring technique.
- Conditions
- Hemodynamics
- Being tested
- Cardiotronic ICON continuous non-invasive cardiac output monitor.
- Keywords
- pediatric, thoracoscopic, cardiometry, cardiac output, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiotronic ICON continuous non-invasive cardiac output monitor.Device
cardiac index, cardiac output \& stroke volume measured and recorded with every change in intrathoracic pressure.
| Study group | Role | What they receive |
|---|---|---|
| pediatric thoracoscopic group | record hemodynamic changes and cardiac output at different intrathoracic pressures ( insufflation pressures 4, 5, 6 mmHg) Receives: Device: Cardiotronic ICON continuous non-invasive cardiac output monitor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Cardiac index
L/min/m2
Measured: measured before inflation, 1 minute after inflation of the thoracic cavity at 4 mm Hg, 5 mm Hg and 6 mm Hg and after deflation
Secondary outcomes (5)
non invasive blood pressure
mmHg
Measured: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure and after deflation till end of surgery
heart rate
beats per minute
Measured: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
stroke volume
millilitres
Measured: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
systemic vascular resistance
dynes/seconds/cm-5
Measured: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
cardiac output
l/min
Measured: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Nov 2019
- Primary completion31 Dec 2019
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd el moneim Soaida, MD, Cairo University
- Investigators
- Sherif M Soaida, A. professor, Study director, faculty of medicine, Cairo university, EgyptSara Abd EL Salam, lecturer, Study director, faculty of medicine, Cairo university, EgyptMaha G Hanna, professor, Study chair, faculty of medicine, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131699
- Sponsor's protocol ID
- SMS2019-1
- Status last verified
- Jan 2020
- First submitted
- 14 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Velocimetry (ICON Cardiometry) Assessment of Hemodynamic Changes With Different Inflation Pressures During Pediatric Thoracoscopic Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT04131699
- Acronym / sponsor ID
- SMS2019-1
- Conditions
- Hemodynamics
- Keywords
- pediatric, thoracoscopic, cardiometry, cardiac output, hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 18 Oct 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.
Advances in endoscopic equipment and technique have led to the use of minimally invasive thoracic surgery in an increasing number of pediatric surgical procedures. Logically, thoracoscopic surgery and anesthesia can induce significant physiologic changes,, derangements of normal respiratory physiology induced by the surgical approach and the installation of carbon dioxide into the thoracic cavity can lead to alterations of normal acid-base status. Finally, surgical procedures in the chest, surgical traction or insufflation pressures impairs venous return and/or cardiac function, especially in neonates and infants. In this study Electrical Cardiometry TM (ICON, Cardiotronic/Osypka Medical, Inc., La Jolla CA, USA) is used assess the effect of different intra-thoracic pressure (insufflation pressures 4,5 \& 6 mmHg) during thoracoscopic surgeries in neonates and infants on hemodynamics using electrical velocimetry (ICON) as non-invasive monitoring technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric thoracoscopic group | – | Device: Cardiotronic ICON continuous non-invasive cardiac output monitor.record hemodynamic changes and cardiac output at different intrathoracic pressures ( insufflation pressures 4, 5, 6 mmHg) |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants and neonates who are a candidate for thoracoscopic surgeries, and suffer no congenital heart disease.
Key inclusion criteria (3 listed)
- ASA physical status I-II.
- Age neonates and infants
- Children undergoing thoracoscopic surgery surgeries.
Key exclusion criteria (3 listed)
- Parents' or guardians' refusal.
- Left lateral positioning
- Congenital heart diseases.
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 |
|---|---|---|
| Cardiotronic ICON continuous non-invasive cardiac output monitor.cardiac index, cardiac output \& stroke volume measured and recorded with every change in intrathoracic pressure. | Device | pediatric thoracoscopic group |
Primary outcome
change in Cardiac index
Time frame: measured before inflation, 1 minute after inflation of the thoracic cavity at 4 mm Hg, 5 mm Hg and 6 mm Hg and after deflation
L/min/m2
5 secondary outcomes
non invasive blood pressure
Time frame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure and after deflation till end of surgery
heart rate
Time frame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
stroke volume
Time frame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
systemic vascular resistance
Time frame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
cardiac output
Time frame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
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 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sherif M Soaida, A. professor study director
faculty of medicine, Cairo university, Egypt
Sara Abd EL Salam, lecturer study director
faculty of medicine, Cairo university, Egypt
Maha G Hanna, professor study chair
faculty of medicine, Cairo university, Egypt
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 Hemodynamics, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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 13 Jan 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 Egypt. 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?
change in Cardiac index (time frame: measured before inflation, 1 minute after inflation of the thoracic cavity at 4 mm Hg, 5 mm Hg and 6 mm Hg and after deflation). 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 13 Jan 2020.