Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03869606
Other study ID # 1808715198
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date April 1, 2020

Study information

Verified date July 2020
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will be the first of several studies that establish the value of measuring fluid responsiveness in children undergoing general anesthesia. The first study in this series will determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in normal children before and after passive leg raising, predicts changes in stroke volume, cardiac output, and blood pressure during the early stages of anesthesia. A second study will determine if early treatment of the fluid responsiveness will prevent the decline in blood pressure that accompanies general anesthesia. If the NICOM monitor permits accurate prediction in normal patients, future studies of pediatric patients undergoing major surgery would be indicated.

The investigators would like to add 25 additional patients who will have the NICOM assessments performed in the pre operative area - Pre anesthesia. General anesthesia may alter the results of the NICOM assessments. The investigators will use these 25 subjects to serve as a comparison/control group.


Description:

Eligible patients will be identified from the surgery schedule and will be contacted by a research team member via phone ahead of their surgery date to inform them of the research study. This call will allow the research team member to answer questions and establish the subject's interest in participation. If interested, or not able to be contacted by phone, patient/family will be approached in the pre-operative area or other private hospital setting. He/she and their parent(s) will have ample time to read the consent and ask any questions regarding the study.

If the subject and his/her parent(s) agree to participate, all standard techniques for general anesthesia compatible with the particular surgical procedure will be employed. Clinical decisions concerning the subject's perioperative care will be made by the anesthesiologist of record.

Cardiac output will be measured with the NICOM cardiac output monitor. The NICOM is a non-invasive monitor using bioreactance, a proprietary technique developed by Cheetah Medical that utilizes delay time shifts to measure stroke volume when an alternating current is passed through the thorax. It requires the placement of four surface electrodes (similar to ECG electrodes) above and below the heart on each side of the patient's chest.

This study will measure cardiac output, stroke volume, and fluid responsiveness (increase in stroke volume > 10%) obtained via passive leg elevation immediately after induction of anesthesia. Adult studies have demonstrated that fifty percent of fasted patients are fluid responsive. The investigators seek to determine the incidence on children.

All decisions concerning clinical care of the subject during the perioperative period will made by the anesthesiologist of record in accordance with accepted standard of care.

1. The NICOM® electrodes will be applied in proper position in the pre-op area. In pre-op, baseline and passive leg measurements will be recorded using the NICOM®. Electrodes will remain in place and will again be used during the OR NICOM® measurements.

2. Standard physiologic monitors will be used: non-invasive blood pressure, ECG, pulse oximeter, capnograph (end-tidal carbon dioxide), BIS (bispectral analsysis/depth of anesthesia).

3. Induction of anesthesia to be determined by the anesthesiologist of record. May be either inhalation or intravenous.

4. Measurements recorded after application of NICOM electrodes include blood pressure, heart rate, end-tidal carbon dioxide, arterial oxygen saturation, BIS level, stroke volume, cardiac output.

5. After measurement of baseline cardiorespiratory parameters, passive leg elevation to 45 degrees will be performed.

6. Cardiorespiratory measurements describe in section d will be repeated after passive leg elevation.

7. Cardiorespiratory parameters will be measured during the next 60 minutes of anesthesia. This information will be used to determine whether fluid responsive patients require additional intravenous fluids or vasoactive drugs during the course of anesthesia.

The same procedures listed above will be performed Pre-anesthesia in the Pre operative area, while the subject is fully awake.

General anesthesia may alter the results of the NICOM procedures. The investigators will add 25 patients who will be evaluated with the study procedures pre anesthesia as a control/comparison group.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 17 Years
Eligibility Inclusion Criteria:

- Patients 11 to no older than 17 years of age

Exclusion Criteria:

- severed developmental delay,

- orthopedic patients with leg injuries

- injury that would prevent passive leg elevation.

- severe aortic insufficiency,

- severe anatomic abnormalities of the thoracic aorta

- patients with external cardiac pacemakers. close

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NICOM by Cheetah Medical
Observational measurement, Cardiac Output, Pre- and Post Anesthesia

Locations

Country Name City State
United States Riley Hospital for Children Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac Output via NICOM monitor Stroke volume x Heart Rate = Cardiac Output Pre-Induction and fifteen minutes up to thirty minutes Post-Anesthesia Induction
See also
  Status Clinical Trial Phase
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT01981954 - A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO) Phase 3
Completed NCT02199626 - SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD). Phase 4
Recruiting NCT04679792 - Postual Control in Pediatric Chiari I Malformation
Recruiting NCT06061159 - The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction Phase 4
Active, not recruiting NCT05453968 - Berotralstat Treatment in Children With Hereditary Angioedema Phase 3
Not yet recruiting NCT02182648 - Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction Phase 4
Active, not recruiting NCT04176640 - Quantifying Brain Injury on Computed Tomography in Hospitalized Children
Active, not recruiting NCT06146452 - Micronutrient Status in Pediatric Palliative Care
Completed NCT04041180 - Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .
Not yet recruiting NCT06165003 - Examination of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices N/A
Recruiting NCT02286297 - Pediatric Endotracheal Intubation During Resuscitation N/A
Unknown status NCT00613184 - Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses N/A
Recruiting NCT00265772 - Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis Phase 4
Completed NCT04106063 - A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Not yet recruiting NCT06376643 - Augmented Reality to Support Cardiopulmonary Resuscitation N/A
Not yet recruiting NCT05511233 - ERAS Protocol in Newborns: CARES Study N/A
Not yet recruiting NCT04127968 - Efficacy and Safety of Vitamin A Treatment for Children With Sepsis N/A
Active, not recruiting NCT04472286 - Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors
Recruiting NCT04988516 - Virtual Reality Distraction for Anxiety (VR-IMAGINE) N/A