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Comparison of Fluid Capture Efficiency of the Total Capture Drape Versus a Standard Drape for Hysteroscopy

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ClinicalTrials.gov Identifier: NCT04540952
Recruitment Status : Terminated (COVID-19)
First Posted : September 7, 2020
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
North Carolina Biotechnology Center
Information provided by (Responsible Party):
Paul Bartow Marshburn, Atrium Health

Brief Summary:

Safety during operative hysteroscopy requires a fluid management system to assist in gauging patient fluid absorption of media used for visualizing the uterine cavity. Serious patient complications, including hyponatremia (low serum sodium), heart failure, and pulmonary and cerebral edema, can result from over absorption of this distending medium. Failure of surgical drapes to collect unabsorbed fluid causes inaccurate determination of the hysteroscopic fluid deficit (HD) thus preventing proper risk evaluation for patient fluid overload, could prompt premature procedure terminatio, and result in hazards for the OR team.

Specific Aims:

  1. To perform a comparative trial of the "Total Capture" hysteroscopy drape (TCD) versus the standard drape during patient surgeries to document improved, real-time determination of patient fluid absorption. Pilot testing of a prototype design of the "Total Capture drape" versus the conventional hysteroscopy drape indicated remarkable improvement in fluid capture and accurate fluid deficit determination in a plastic pelvic model experiment.
  2. To evaluate the clinical usefulness of the TCD compared to the Standard drape for hysteroscopy with the standardized metrics of: 1) the Technology Acceptance Model, and 2) The System Usability Scale. These metrics will allow us to quantitate clinical usefulness and usability of both the operating surgeons and operating room staff.

The investigators hypothesize the "Total Capture" Drape design provides an accurate recorded hysteroscopic fluid deficit in real-time so that patient safety and surgical parameters are optimized. The simple design of the TCD would add a very significant improvement for patient safety and care with minimal cost for the estimated 200,000 hysteroscopies performed per year in the U.S.


Condition or disease Intervention/treatment Phase
Hysteroscopic Surgery Device: Total Capture Drape Device: Standard Hysteroscopy Drape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Block randomization of patients without their knowledge of grouping. Surgical providers become aware of randomized drape selection only at the time of hysteroscopy. Principal investigator blinded to selection and results.
Primary Purpose: Other
Official Title: A Prospective, Randomized Trial to Compare the Fluid Capture Efficiency of the "Total Capture" Drape Versus a Standard Drape for Hysteroscopy: Innovation for Improved Patient Safety and Surgical Care.
Actual Study Start Date : January 9, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
Experimental: Total Capture Drape
Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
Device: Total Capture Drape
Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure

Active Comparator: Control
Standard surgical drape used to adequately collect fluid during hysteroscopy procedure
Device: Standard Hysteroscopy Drape
Standard surgical drape used to adequately collect fluid during hysteroscopy procedure




Primary Outcome Measures :
  1. Hysteroscopic fluid deficit (HFD) measured by the fluid management system by subtracting the outflow volume (OV) returned to the fluid management system from the inflow volume (IV). [ Time Frame: 1 day (day of procedure) ]

    The primary outcome variable for the comparative trial will be the hysteroscopy fluid deficit (HFD) which can be precisely measured by the fluid management system by subtracting the outflow volume (OV) returned to the fluid management system from the inflow volume (IV). That is:

    HFD = IV - OV



Secondary Outcome Measures :
  1. Uncollected distention fluid volume found on operating room floor and bedding [ Time Frame: 1 day (day of procedure) ]
    Distention fluid medium not collected and found on operating room floor and bedding

  2. Measures for Drape Usability, Quality, and Convenience using the System Usability Scale [ Time Frame: 1 day (day of procedure) ]
    Objective and subjective evaluation of the usability and usefulness of the total capture drape compared to the standard drape. Measurements determined by the System Usability Scale. The unit of assessment is the total SUS score which is out of 100.

  3. Measures for Drape Usability, Quality, and Convenience using the Human Factors Assessment tool, feedback and focus group sessions with operating surgeons and operating room staff [ Time Frame: 1 day (day of procedure and day of focus group) ]
    Objective and subjective evaluation of the usability and usefulness of the total capture drape compared to the standard drape. Measurements determined by the System Usability Scale. The unit of assessment is the total SUS score which is out of 100.the Human Factors Assessment tool and feedback or focus group sessions with operating surgeons and operating room staff. The unit of assessment is the identified themes from qualitative analysis.

  4. Adverse Events encountered with either of the drape study arms [ Time Frame: 1 day (day of procedure) ]
    Complications encountered with either of the drape study arms: minor severe

  5. Hysteroscopy fluid management alarm activation by unsafe level of patient fluid absorption [ Time Frame: 1 day (day of procedure) ]
    Indicates unsafe level of patient fluid absorption

  6. Procedure interruption due to concerns of overabsorption by the patient [ Time Frame: 1 day (day of procedure) ]
    Stopping of the operation due to concerns of overabsorption by the patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who are scheduled for a hysteroscopy that require a fluid management system at an Atrium Health operating room facility.

Exclusion Criteria:

  • Women will be excluded if they are not acceptable candidates for a hysteroscopy procedure for any reason.

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): NCT04540952


Locations
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United States, North Carolina
Atrium Health
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Atrium Health
North Carolina Biotechnology Center
Investigators
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Principal Investigator: Paul B. Marshburn, MD Atrium Health
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Responsible Party: Paul Bartow Marshburn, Principal Investigator, Atrium Health
ClinicalTrials.gov Identifier: NCT04540952    
Other Study ID Numbers: 04-16-07B
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patients personal health information are confidential. All patient data are de-identified for analysis and reporting

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Paul Bartow Marshburn, Atrium Health:
hysteroscopy
fluid management
safety
surgical complications
surgical drape