General AnesthesiaNCT06383000
Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes
An observational study of General Anesthesia and Blood Pressure, run by BLZ Technology (Wuhan) Co.,Ltd.
Trial summary
The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter… Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- General Anesthesia, Blood Pressure, Pulse Rate
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Dec 2024
- 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 4 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients are going to undergoing a general anesthetic surgery for more than 60 minutes at the site (Tongji Hospital, Tongji Medical College of HUST) who are accord with the inclusion criteria and do not satisfy the exclusion criteria.
Who may be able to join
- Patients undergoing general anesthesia surgeries for more than 60 minutes with IBP monitoring
- Patients aging between 4 to 80 years old (including at least 5 pediatric subjects between 4 to 12 years old, and as for subjects over 12 years old, up to 60% of subjects between 12 to 50 years old, at least 15% of subjects between 50 to 60 years old, at least 15% of subjects between 60 to 70 years old, and at least 10% of subjects over 70 years old)
- At least 30% of subjects is male and 30% is female
- Volunteer to participate the study and sign the informed consent form willingly
Who cannot join
- Patients with severe heart diseases which affect the stability of haemodynamics
- Patients applied with the heart-lung machine, defibrillator or cardiopulmonary bypass
- Patients with coagulation disorders, vasculopathy or vascular prostheses
- Patients with cutaneous diseases, infections or trauma of the measured part of the body leading to failure of data acquisition
- Patients with mental diseases, epilepsy or other diseases leading to involuntrary movements of the body
- Patients with BMI no more than 17 or no less than 30 kg/m^2
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- Patients who are pregnant or at the unstable stage of diseases or with severe shock
- Patients with infections or trauma at the position of artery cannulation, whose pulse is untouchable or who get positive in the Allen's test
- Patients with diseases that the investigators think unsuitable for participating the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of the Effectiveness of the Continuous Non-invasive Haemodynamic Monitor
The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.
Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.
Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200.
- Conditions
- General Anesthesia, Blood Pressure, Pulse Rate, Arterial Line
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Non -invasive Blood Pressure Measurement from MOH200
The blood pressure is measured by MOH200 and recorded on the CRF for every 5 minutes, including mean blood pressure, diastolic blood pressure and systolic blood pressure.
Measured: During the surgery
Invasive Blood Pressure Measurement from Arterial Line
The blood pressure is synchronously measured by the radial arterial line and also recorded on the CRF for every 5 minutes, including mean arterial pressure, diastolic blood pressure and systolic blood pressure.
Measured: During the surgery
Pulse Rate Measurement from MOH200
The pulse rate is measured by the MOH200 and recorded on the CRF for every 5 minutes.
Measured: During the surgery
Pulse Rate Measurement from Pulse Oximeter
The pulse rate is measured by the pulse oximeter and recorded on the CRF for every 5 minutes during the surgery.
Measured: During the surgery
Secondary outcomes (1)
The Occurrence of Pressure Pores
In order to evaluate the safety of the haemodynamic monitor MOH200, the occurrence of device-related pressure pores is recorded. The incidence of adverse reactions=(the number of pressure sore occurrence/the total number of subjects observed)×100%
Measured: Once after all the subjects are recruited and the clinical trials are finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BLZ Technology (Wuhan) Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiqiang Zhou, Principal investigator, Department of Anesthesiology, Tongji Hospital, Tongji Medical College of HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383000
- Sponsor's protocol ID
- BLZ2024MOH
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of the Continuous Non-invasive Haemodynamic Monitor
- ClinicalTrials.gov ID
- NCT06383000
- Acronym / sponsor ID
- BLZ2024MOH
- Conditions
- General Anesthesia, Blood Pressure, Pulse Rate, Arterial Line
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- BLZ Technology (Wuhan) Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Apr 2024 (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 goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.
Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.
Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are going to undergoing a general anesthetic surgery for more than 60 minutes at the site (Tongji Hospital, Tongji Medical College of HUST) who are accord with the inclusion criteria and do not satisfy the exclusion criteria.
Key inclusion criteria (4 listed)
- Patients undergoing general anesthesia surgeries for more than 60 minutes with IBP monitoring
- Patients aging between 4 to 80 years old (including at least 5 pediatric subjects between 4 to 12 years old, and as for subjects over 12 years old, up to 60% of subjects between 12 to 50 years old, at least 15% of subjects between 50 to 60 years old, at least 15% of subjects between 60 to 70 years old, and at least 10% of subjects over 70 years old)
- At least 30% of subjects is male and 30% is female
- Volunteer to participate the study and sign the informed consent form willingly
Key exclusion criteria (9 listed)
- Patients with severe heart diseases which affect the stability of haemodynamics
- Patients applied with the heart-lung machine, defibrillator or cardiopulmonary bypass
- Patients with coagulation disorders, vasculopathy or vascular prostheses
- Patients with cutaneous diseases, infections or trauma of the measured part of the body leading to failure of data acquisition
- Patients with mental diseases, epilepsy or other diseases leading to involuntrary movements of the body
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
Continuous Non -invasive Blood Pressure Measurement from MOH200
Time frame: During the surgery
The blood pressure is measured by MOH200 and recorded on the CRF for every 5 minutes, including mean blood pressure, diastolic blood pressure and systolic blood pressure.
Invasive Blood Pressure Measurement from Arterial Line
Time frame: During the surgery
The blood pressure is synchronously measured by the radial arterial line and also recorded on the CRF for every 5 minutes, including mean arterial pressure, diastolic blood pressure and systolic blood pressure.
Pulse Rate Measurement from MOH200
Time frame: During the surgery
The pulse rate is measured by the MOH200 and recorded on the CRF for every 5 minutes.
Pulse Rate Measurement from Pulse Oximeter
Time frame: During the surgery
The pulse rate is measured by the pulse oximeter and recorded on the CRF for every 5 minutes during the surgery.
1 secondary outcome
The Occurrence of Pressure Pores
Time frame: Once after all the subjects are recruited and the clinical trials are finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
Zhiqiang Zhou principal investigator
Department of Anesthesiology, Tongji Hospital, Tongji Medical College of HUST
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Blood Pressure, run by BLZ Technology (Wuhan) Co.,Ltd.
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 4 inclusion and 9 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Zhiqiang Zhou (+86-13886043314, 328667192@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Non -invasive Blood Pressure Measurement from MOH200 (time frame: During the surgery). The study lists 4 primary outcomes in all. 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 Apr 2024.