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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.

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.

Condition or disease Intervention/treatment Phase
Pain Device: Cryoanalgesia Drug: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : March 4, 2019
Actual Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryoanalgesia + Standard of Care (SOC)
Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
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

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.
Drug: Standard of Care
Institutional SOC for pain management will be followed.
Other Name: SOC




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922153


Locations
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United States, California
University of Southern California (USC)
Los Angeles, California, United States, 90033
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
United Heart and Vascular Institute - Allina
Saint Paul, Minnesota, United States, 55102
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: Wei Lau, MD William Beaumont Hospitals
  Study Documents (Full-Text)

Documents provided by AtriCure, Inc.:
Informed Consent Form  [PDF] September 26, 2016

Publications:

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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02922153    
Other Study ID Numbers: CP2015-4
First Posted: October 4, 2016    Key Record Dates
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AtriCure, Inc.:
CryoAnalgesia
Thoracotomy
Forced Expiratory Volume (FEV1)
Visual Analog Scale (VAS)