Trial Outcomes & Findings for Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia. (NCT NCT01928797)

Results Overview

To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurements. After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

intraoperatively during surgery

Results posted on

2017-11-14

Participant Flow

Start Date: November 2013 Types of location: Brigham and Women's Hospital Labor and Delivery Unit

Participant milestones

Participant milestones
Measure	Control Group Vasopressor use based on blood pressure and heart rate. Cardiac output data was blinded to the care providers.	Study Group Vasopressor use based on the cardiac output, blood pressure and heart rate.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=30 Participants cardiac output monitor will be attached CO values will not be used to guide vasopressor use. The care provider will use blood pressure and heart rate data to guide vasopressor use.	Study Group n=30 Participants cardiac output monitor will be attached CO values will guide vasopressor use in addition blood pressure and heart rate	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.1 years STANDARD_DEVIATION 5.6 • n=5 Participants	34.3 years STANDARD_DEVIATION 5.3 • n=7 Participants	34.2 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Cardiac Output	6.3 L/min STANDARD_DEVIATION 1.3 • n=5 Participants	6.5 L/min STANDARD_DEVIATION 1.3 • n=7 Participants	6.4 L/min STANDARD_DEVIATION 74 • n=5 Participants

PRIMARY outcome

Timeframe: intraoperatively during surgery

To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurements. After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values.

Outcome measures

Outcome measures
Measure	Control Group n=30 Participants cardiac output monitor will be attached but CO values will not guide vasopressor use as CO data is blinded to care provider	Study Group n=30 Participants cardiac output monitor will be attached and CO data used to guide management based on the protocol
Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values Percent incidences (CO within 20% baseline)	71 percentage of patients	66 percentage of patients
Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values Percent incidences (CO outside 20% baseline	29 percentage of patients	34 percentage of patients

SECONDARY outcome

Timeframe: intraoperatively during surgery

Population: Nausea

incidence of nausea, and vomiting

Outcome measures

Outcome measures
Measure	Control Group n=30 Participants cardiac output monitor will be attached but CO values will not guide vasopressor use as CO data is blinded to care provider	Study Group n=30 Participants cardiac output monitor will be attached and CO data used to guide management based on the protocol
Nausea and Vomiting Incidence of vomiting	1 Participants	1 Participants
Nausea and Vomiting Incidence of Nausea	9 Participants	9 Participants

SECONDARY outcome

Timeframe: Intraoperative

Population: 1 out of 30 babies had umbilical pH \< 7.2

Number of participants with Umbilical cord pH \<7.2

Outcome measures

Outcome measures
Measure	Control Group n=30 Participants cardiac output monitor will be attached but CO values will not guide vasopressor use as CO data is blinded to care provider	Study Group n=30 Participants cardiac output monitor will be attached and CO data used to guide management based on the protocol
Number of Participants With Umbilical Cord pH	1 number of participants	0 number of participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Group n=30 participants at risk cardiac output monitor will be attached but will not guide treatment based on cardiac output. The treatment will be based on blood pressure changes.	Study Group n=30 participants at risk cardiac output monitor will be attached CO values will guide vasopressor protocol use
Gastrointestinal disorders vomiting	3.3% 1/30 • Number of events 1 • Intraoperative period	0.00% 0/30 • Intraoperative period

Additional Information

Dr. Bhavani Kodali

Brigham and Women's Hospital

Phone: 617-732-8220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place