Inadequate; Pulmonary Function, NewbornNCT03205943
Use of ICON™ to Detect Hemodynamic Variables During Dexmedetomidine Sedation in Children Undergoing Pulmonary Function Test
An observational study of Inadequate; Pulmonary Function, Newborn, run by Boston Children's Hospital.
Trial summary
To collect and analyze the physiologic data of the ICON™ during dexmedetomidine (DEX) sedation for neonatal pulmonary function testing. The ICON™ is a noninvasive physiological monitor which uses respiratory impedance to follow systemic vascular resistance (SVR), heart rate, cardiac index and stroke index. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Inadequate; Pulmonary Function, Newborn
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients 1-18 months, undergoing pulmonary function testing
Who may be able to join
- Patients who are 1-18 months of age, scheduled for pulmonary function testing and eligible for sedation with dexmedetomidine and whose family agree to participate in the study
Who cannot join
- Patients with the following diagnoses are not medically appropriate to receive nursing administered sedation with dexmedetomidine:
- Active, uncontrolled gastroesophageal reflux - an aspiration risk
- Active, uncontrolled vomiting - an aspiration risk
- Current (or within past 3 months) history of apnea requiring an apnea monitor
- Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
- Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
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- Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
- History of digoxin use
- Moya-Moya disease
- New-onset stroke
- In addition, the following are contraindications to the use of the ICON™:
- Pacemakers
- Mitral or aorta valve dysfunction
- Dextrocardia
- Second or third degree heart block
- Current diagnosis of cardiac, pulmonary, hepatic or renal failure
- Current diagnosis of pulmonary masses/tumor/pleural effusions/pneumonia/edema
- Pericardial effusion
- Large implanted thoracic metallic devices (including orthodontic braces, spine rods, plates and screws)
- Allergy to device standard BCH ECG electrodes (Vermed A 10061-SRT disposable prewired medical electrodes)
About this study
Official title: Use of a Non-invasive Bio-impedance Cardiac Monitor, ICON™, to Detect and Trend Hemodynamic Variables During Dexmedetomidine Sedation in Children Undergoing Pulmonary Function Testing
To collect and analyze the physiologic data of the ICON™ during dexmedetomidine (DEX) sedation for neonatal pulmonary function testing. The ICON™ is a noninvasive physiological monitor which uses respiratory impedance to follow systemic vascular resistance (SVR), heart rate, cardiac index and stroke index.
Read the detailed description
Traditionally the measurements of cardiac indices and hemodynamic variables require invasive monitors such as pulmonary thermodilution catheters and transesophageal Doppler echocardiography. In recent years, electrical cardiometry has been used for the non-invasive determination of stroke volume, cardiac output, and other hemodynamic parameters in adults, children, and neonates. Electrical cardiometry has been validated against "gold standard" methods such as thermodilution and is a proprietary method trademarked by Cardiotronic, Inc. (La Jolla, CA). Cardiotronic markets the ICON™. It is FDA-approved for use in pediatric and adult patients, is currently used for clinical purposes in the BCH MSICU at 11 South.
The ICON™ is a comprehensive, standalone hemodynamic monitor, which provides a complete hemodynamic monitoring system that provides user-defined hemodynamic parameters. It provides a continuous trend of cardiac output and stroke volume associated with rapid changes in vital signs with minimal risk to the patient.
The ICON™ monitor has been used in Boston Children's Hospital to determine the hemodynamic changes in children aged 1 month to 18 years of age who received dexmedetomidine sedation for CT and Nuclear Medicine.
Dexmedetomidine (DEX) has been found to be an effective drug in the pediatric population in both the intensive care unit and for procedures in Radiology. In a recent study, DEX caused bradycardia (3%), hypotension (9%) and hypertension (8%) in pediatric critical care patients. Intravenously administrated sedation. DEX will be delivered as per the DEX order set used for non-painful procedures in the radiology department. As an alpha 2 adrenergic agonist, DEX produces hemodynamic changes to blood pressure and heart rate. To precisely follow the trend of complex changes in systemic vascular resistance, cardiac output and stroke volume during DEX administration, would ideally be with invasive intravascular monitors which would not be warranted in pediatric sedation procedures. However, a minimal risk non-invasive cardiac output monitor such as the ICON can measure, detect, and trend these physiological changes in the neonates and infants who are receiving DEX for pulmonary function tests.
Children with certain lung conditions undergo pulmonary function tests (PFT) which are currently being performed using chloral hydrate administered by the responsible and sedation credentialed pulmonologist (Dr. Lawrence Rhein). Chloral hydrate is inconsistent and unreliable in producing adequate sedation for a successful PFT study. Sedation physicians from the BCH Department of Anesthesia have agreed to provide sedation for these patients with dexmedetomidine (DEX), using the same approved protocols that are being used in the BCH Department of Radiology for non-painful imaging studies.
Investigators will use the ICON™ to follow the physiological cardiac parameters (non-invasive blood pressure, pulse oximeter, capnography, heart rate, and electrocardiogram) throughout the pre-sedation, sedation and recovery period. Investigators propose collecting this data in a prospective manner with parental informed consent for the data collection.
- Conditions
- Inadequate; Pulmonary Function, Newborn
- Keywords
- ICON
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate
The changes in heart rate from baseline, during the DEX administration and sedation and during recovery period (following discontinuation of the DEX) through time of discharge.
Measured: Up to 12 hours
Changes in blood pressure
The changes in blood pressure from baseline, during the DEX administration and sedation and during recovery period (following discontinuation of the DEX) through time of discharge.
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: logistical challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inadequate; Pulmonary Function, NewbornStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keira Mason, Boston Children's Hospital
- Investigators
- Keira Mason, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205943
- Sponsor's protocol ID
- P00008608
- Status last verified
- Jun 2017
- First submitted
- 28 Jul 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Snapir A, Posti J, Kentala E, Koskenvuo J, Sundell J, Tuunanen H, Hakala K, Scheinin H, Knuuti J, Scheinin M. Effects of low and high plasma concentrations of dexmedetomidine on myocardial perfusion and cardiac function in healthy male subjects. Anesthesiology. 2006 Nov;105(5):902-10; quiz 1069-70. doi: 10.1097/00000542-200611000-00010.
PubMed 17065883Wong J, Steil GM, Curtis M, Papas A, Zurakowski D, Mason KP. Cardiovascular effects of dexmedetomidine sedation in children. Anesth Analg. 2012 Jan;114(1):193-9. doi: 10.1213/ANE.0b013e3182326d5a. Epub 2011 Sep 29.
PubMed 21965374
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Non-invasive Bio-impedance Cardiac Monitor, ICON™, to Detect and Trend Hemodynamic Variables During Dexmedetomidine Sedation in Children Undergoing Pulmonary Function Testing
- ClinicalTrials.gov ID
- NCT03205943
- Acronym / sponsor ID
- P00008608
- Conditions
- Inadequate; Pulmonary Function, Newborn
- Keywords
- ICON
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: logistical challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect and analyze the physiologic data of the ICON™ during dexmedetomidine (DEX) sedation for neonatal pulmonary function testing. The ICON™ is a noninvasive physiological monitor which uses respiratory impedance to follow systemic vascular resistance (SVR), heart rate, cardiac index and stroke index.
Detailed description
Traditionally the measurements of cardiac indices and hemodynamic variables require invasive monitors such as pulmonary thermodilution catheters and transesophageal Doppler echocardiography. In recent years, electrical cardiometry has been used for the non-invasive determination of stroke volume, cardiac output, and other hemodynamic parameters in adults, children, and neonates. Electrical cardiometry has been validated against "gold standard" methods such as thermodilution and is a proprietary method trademarked by Cardiotronic, Inc. (La Jolla, CA). Cardiotronic markets the ICON™. It is FDA-approved for use in pediatric and adult patients, is currently used for clinical purposes in the BCH MSICU at 11 South.
The ICON™ is a comprehensive, standalone hemodynamic monitor, which provides a complete hemodynamic monitoring system that provides user-defined hemodynamic parameters. It provides a continuous trend of cardiac output and stroke volume associated with rapid changes in vital signs with minimal risk to the patient.
The ICON™ monitor has been used in Boston Children's Hospital to determine the hemodynamic changes in children aged 1 month to 18 years of age who received dexmedetomidine sedation for CT and Nuclear Medicine.
Dexmedetomidine (DEX) has been found to be an effective drug in the pediatric population in both the intensive care unit and for procedures in Radiology. In a recent study, DEX caused bradycardia (3%), hypotension (9%) and hypertension (8%) in pediatric critical care patients. Intravenously administrated sedation. DEX will be delivered as per the DEX order set used for non-painful procedures in the radiology department. As an alpha 2 adrenergic agonist, DEX produces hemodynamic changes to blood pressure and heart rate. To precisely follow the trend of complex changes in systemic vascular resistance, cardiac output and stroke volume during DEX administration, would ideally be with invasive intravascular monitors which would not be warranted in pediatric sedation procedures. However, a minimal risk non-invasive cardiac output monitor such as the ICON can measure, detect, and trend these physiological changes in the neonates and infants who are receiving DEX for pulmonary function tests.
Children with certain lung conditions undergo pulmonary function tests (PFT) which are currently being performed using chloral hydrate administered by the responsible and sedation credentialed pulmonologist (Dr. Lawrence Rhein). Chloral hydrate is inconsistent and unreliable in producing adequate sedation for a successful PFT study. Sedation physicians from the BCH Department of Anesthesia have agreed to provide sedation for these patients with dexmedetomidine (DEX), using the same approved protocols that are being used in the BCH Department of Radiology for non-painful imaging studies.
Investigators will use the ICON™ to follow the physiological cardiac parameters (non-invasive blood pressure, pulse oximeter, capnography, heart rate, and electrocardiogram) throughout the pre-sedation, sedation and recovery period. Investigators propose collecting this data in a prospective manner with parental informed consent for the data collection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients 1-18 months, undergoing pulmonary function testing
Key inclusion criteria (1 listed)
- Patients who are 1-18 months of age, scheduled for pulmonary function testing and eligible for sedation with dexmedetomidine and whose family agree to participate in the study
Key exclusion criteria (20 listed)
- Patients with the following diagnoses are not medically appropriate to receive nursing administered sedation with dexmedetomidine:
- Active, uncontrolled gastroesophageal reflux - an aspiration risk
- Active, uncontrolled vomiting - an aspiration risk
- Current (or within past 3 months) history of apnea requiring an apnea monitor
- Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in heart rate
Time frame: Up to 12 hours
The changes in heart rate from baseline, during the DEX administration and sedation and during recovery period (following discontinuation of the DEX) through time of discharge.
Changes in blood pressure
Time frame: Up to 12 hours
The changes in blood pressure from baseline, during the DEX administration and sedation and during recovery period (following discontinuation of the DEX) through time of discharge.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 17065883Snapir A, Posti J, Kentala E, Koskenvuo J, Sundell J, Tuunanen H, Hakala K, Scheinin H, Knuuti J, Scheinin M. Effects of low and high plasma concentrations of dexmedetomidine on myocardial perfusion and cardiac function in healthy male subjects. Anesthesiology. 2006 Nov;105(5):902-10; quiz 1069-70. doi: 10.1097/00000542-200611000-00010.
- Background: PubMed 21965374Wong J, Steil GM, Curtis M, Papas A, Zurakowski D, Mason KP. Cardiovascular effects of dexmedetomidine sedation in children. Anesth Analg. 2012 Jan;114(1):193-9. doi: 10.1213/ANE.0b013e3182326d5a. Epub 2011 Sep 29.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keira Mason, MD principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Inadequate; Pulmonary Function, Newborn, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate (time frame: Up to 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205943, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.