Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hypotension

Clinical Trial Details

NCT number	NCT02872896
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	N/A
Start date	October 2016
Completion date	September 2018

View Details

See also
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
Suspended	`NCT02315937` - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'	N/A
Completed	`NCT03215797` - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability	Phase 3
Completed	`NCT02907931` - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status	N/A
Recruiting	`NCT02532270` - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring	N/A
Completed	`NCT02437799` - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia	N/A
Completed	`NCT02802683` - Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery	Phase 4
Completed	`NCT01930227` - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients	N/A
Completed	`NCT02146898` - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery	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