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

Launched by BLZ TECHNOLOGY (WUHAN) CO.,LTD · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor blood pressure and pulse rate in patients undergoing surgeries that require general anesthesia for over 60 minutes. Researchers want to see how well the MOH200 device, which measures these vital signs without needing to insert anything into the body, compares to traditional methods that do involve invasive procedures. By doing this, they hope to determine if the MOH200 can be a safe and effective option for monitoring patients during surgery.

To participate in this study, patients must be between 4 and 80 years old and scheduled for a surgery that lasts longer than an hour, where invasive blood pressure monitoring will also be used. Those with certain health conditions, such as severe heart issues or infections, will not be eligible. During the trial, participants will wear the MOH200 alongside standard monitoring devices, and researchers will check for any skin reactions after 30 minutes to ensure the device is safe to use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients undergoing general anesthesia surgeries for more than 60 minutes with IBP monitoring
• • 2. 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)
• • 3. At least 30% of subjects is male and 30% is female
• • 4. Volunteer to participate the study and sign the informed consent form willingly
• Exclusion Criteria:
• • 1. Patients with severe heart diseases which affect the stability of haemodynamics
• • 2. Patients applied with the heart-lung machine, defibrillator or cardiopulmonary bypass
• • 3. Patients with coagulation disorders, vasculopathy or vascular prostheses
• • 4. Patients with cutaneous diseases, infections or trauma of the measured part of the body leading to failure of data acquisition
• • 5. Patients with mental diseases, epilepsy or other diseases leading to involuntrary movements of the body
• • 6. Patients with BMI no more than 17 or no less than 30 kg/m\^2
• • 7. Patients who are pregnant or at the unstable stage of diseases or with severe shock
• • 8. Patients with infections or trauma at the position of artery cannulation, whose pulse is untouchable or who get positive in the Allen's test
• • 9. Patients with diseases that the investigators think unsuitable for participating the study