Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST) (FROST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922153
Recruitment Status : Completed
First Posted : October 4, 2016
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE October 4, 2016
Results First Submitted Date  ICMJE June 2, 2020
Results First Posted Date  ICMJE September 4, 2020
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE June 13, 2016
Actual Primary Completion Date March 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery [ Time Frame: 48-hours post-surgery ]
    Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.
  • Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery [ Time Frame: 48-hours post-surgery ]
    The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Forced Expiratory Volume (FEV1) [ Time Frame: 48-hours post-surgery ]
  • Visual Analogue Scale (VAS) pain in the surgical region [ Time Frame: 48-hours post-surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation [ Time Frame: 48-hours post-extubation ]
    Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced.
  • Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points [ Time Frame: 72-, 96- and 120-hours Post-Op ]
    The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
  • Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit [ Time Frame: 3 and 6 Months ]
    Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place.
  • Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room [ Time Frame: Hours until patient is extubated from time patient leaves the operating room ]
    Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea.
  • Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points [ Time Frame: 24-, 48, -96 and 120-hours ]
    Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay.
  • Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge [ Time Frame: Procedure to Discharge ]
    The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.
  • Secondary Outcome 7: Ambulatory Movement During Hospital Stay [ Time Frame: Baseline, 48, 72, 96, 120 Hours and Discharge ]
    Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Spirometry assessments [ Time Frame: 48-hours post-extubation ]
  • Visual Analogue Scale (VAS) pain [ Time Frame: 72-, 96- and 120-hours Post-Op ]
  • Patient Controlled Analgesia (PCA) [ Time Frame: 24-, 48, -96 and 120-hours Post extubation ]
  • ICU length of stay [ Time Frame: Through discharge from ICU, on average 48-hours post-surgery ]
  • Adverse events related to the CryoAnalgesia procedure or device [ Time Frame: 30-days post-procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Official Title  ICMJE The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Brief Summary The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.
Detailed Description Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Device: Cryoanalgesia
    AtriCure® cryoICE cryo-ablation system
    Other Name: cryoICE
  • Drug: Standard of Care
    Institutional SOC for pain management will be followed.
    Other Name: SOC
Study Arms  ICMJE
  • Experimental: Cryoanalgesia + Standard of Care (SOC)
    Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
    Interventions:
    • Device: Cryoanalgesia
    • Drug: Standard of Care
  • Active Comparator: Standard of Care
    Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.
    Intervention: Drug: Standard of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2020)
84
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2016)
100
Actual Study Completion Date  ICMJE August 28, 2019
Actual Primary Completion Date March 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 - 85 years male or female
  • Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
  • Acceptable surgical candidate, including use of general anesthesia
  • Willing and able to provide written informed consent
  • Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

  • Cardiac valve surgical procedure via conventional full sternotomy
  • Procedures that require a posterolateral thoracotomy
  • Current pregnancy
  • Current use of prescription opioids
  • FEV1 < 40% predicted
  • Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
  • Documented psychiatric disease
  • Documented chronic pain syndrome
  • Documented history of substance abuse
  • Patient currently enrolled in another research study that could directly affect results of either study
  • Physical or mental condition that would interfere with patient's self-assessment of pain
  • Disqualifying medical condition per investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02922153
Other Study ID Numbers  ICMJE CP2015-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AtriCure, Inc.
Study Sponsor  ICMJE AtriCure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Lau, MD William Beaumont Hospitals
PRS Account AtriCure, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP