Hypotension Clinical Trial
Official title:
The Role of Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring During Non-cardiac Surgery
NCT number | NCT02872896 |
Other study ID # | 16-845 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | September 2018 |
Verified date | October 2018 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects will first have a blood pressure reading recorded on both arms using a non-invasive
blood pressure monitoring (NIBP) cuff in the preoperative area. Then blood pressure will be
recorded using the ClearSight monitor on each hand over a one-minute period. If mean arterial
pressure (MAP) as assessed by either the noninvasive blood pressure (NIBP) monitoring cuff or
the ClearSight system differs by more than 10% from arm to arm, the subject will be excluded
from the study.
Before induction of anesthesia, the subject will be randomized to either:
ClearSight group + usual clinical care: Information from ClearSight monitor will be available
to the clinicians. According to ASA guidelines, usual blood pressure monitoring includes
non-invasive blood pressure measurements every 5 minutes during a surgical case.
Non-ClearSight group (blinded) + usual clinical care: Information from ClearSight monitor
will not be available to the clinicians.
Both patient groups will have continuous ClearSight monitoring and non-invasive blood
pressure monitoring every 5 minutes. The difference will be in the intervention group data
from the monitor will be available to the clinicians in the operating room, but in the
control group data from the ClearSight monitor will not be available (blinded) to the
clinicians. Regardless of the study group assignment, second-by-second ClearSight monitor
continuous blood pressure data will be recorded for each study patient and will be used for
analysis.
The morning of post-operative day 3 the subject will be given the QoR-15 questionnaire and
will complete POMS morbidity surveys.
Status | Completed |
Enrollment | 320 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent - Age > 45 years - ASA Physical Status 3 or 4 - Moderate- or high-risk non-cardiac surgical procedures (i.e., orthopedic, spine, urology, and general surgery) in patients in whom invasive blood pressure monitoring is not planned - Anticipated surgical duration >2 hours Exclusion Criteria: - Any contraindications to the proposed interventions - Patient with invasive blood pressure monitoring - Patients with contraindications to oscillometric blood pressure monitoring on one arm and ClearSite monitoring on the other - Preoperative discrepancy in mean arterial pressure >10% between the arms |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time- weighted average (TWA) MAP | 2 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Active, not recruiting |
NCT02016599 -
Effects of Transitional Circulation in ELBW Infants
|
||
Recruiting |
NCT05836610 -
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
|
Phase 4 | |
Completed |
NCT02907931 -
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status
|
N/A | |
Suspended |
NCT02315937 -
Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
|
N/A | |
Completed |
NCT03215797 -
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
|
Phase 3 | |
Recruiting |
NCT02532270 -
Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
|
N/A | |
Completed |
NCT02802683 -
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02437799 -
Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia
|
N/A | |
Completed |
NCT02146898 -
The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
|
N/A | |
Completed |
NCT01930227 -
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
|
N/A | |
Not yet recruiting |
NCT01941472 -
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness
|
N/A | |
Recruiting |
NCT01434251 -
Treatment of Hypotension of Prematurity (TOHOP)
|
N/A | |
Withdrawn |
NCT01183741 -
Accuracy of Non-Invasive Blood Pressure Measurement in Adults
|
Phase 3 | |
Completed |
NCT01592669 -
Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia
|
N/A | |
Completed |
NCT00991627 -
Different Approaches to Maternal Hypotension During Cesarean Section
|
Phase 4 | |
Withdrawn |
NCT00750516 -
Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
|
||
Completed |
NCT00115726 -
Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
|
Phase 4 | |
Recruiting |
NCT05513066 -
Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
|
||
Completed |
NCT04089644 -
Manual vs Closed-loop Control of Mean Arterial Pressure
|
N/A |