Organ Donation Survey Among Health Care Professionals in Argentina

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Unknown status
CT.gov ID
NCT03458052
Collaborator
(none)
200
1
6.5
30.9

Study Details

Study Description

Brief Summary

The aim of this study is to gather information about knowledge, professional experience and attitude toward organ donation among health care professionals involved in the care of potential donors about the procurement process and potential lung donor management nationwide.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The shortage of cadaveric organ donors for transplantation is a global problem. This fact prolongs the time on the waiting list and, therefore, the mortality, which rise to 21.15% in Argentina compared to a world average of 16%. Many reasons can explain the low procurement rate. It has been stated that the conventional ventilatory management for potential lung donors is suboptimal for lung preservation before harvest.

    In Argentina there is limited research regarding the attitude toward organ donation among health care professionals, knowledge of the federal organ procurement program and professional experience in diagnosing brain death and lung donor management. Knowing the Argentinian current situation will make it possible to detect possible organ shortages causes, evaluate strategies to increase the national procurement rate and to instruct the health team that assists neurocritical patients who die of brain death. So we propose the following research.

    The aim of this study is to gather information about knowledge, professional experience and attitude among health care professionals involved in the care of potential donors toward organ donation, procurement process and potential lung donor management nationwide.

    A online questionnaire was designed and distributed among health care professionals register to different scientific societies related to the care of neurocritical patients between febrary 16th and september 1st. The questionnaire consisting of 37 ítems: 6 items measuring attitudes, 6 items measuring knowledge, 16 items investigating professional experience and 9 ítems assessing demographics.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Knowledge, Professional Experience and Attitude Toward Organ Donation Among Health Care Professionals in Argentina: the DonAR Survey
    Actual Study Start Date :
    Feb 16, 2018
    Anticipated Primary Completion Date :
    Apr 1, 2018
    Anticipated Study Completion Date :
    Sep 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Attitude Toward Organ Donation [6 months]

      investigated attitudes regarding organ donation among health care professional: is an organ donor:1, isn´t an organ donor:2, he/she haven´t been decided: 2

    2. Organ Donor Registry [6 months]

      investigated whether the health care professional is a registered organ donor: Yes:1, No:0.

    3. Last will manifest [6 months]

      investigated whether the health care professional´s spouse and / or family knows he/she organ donor attitude towards organ donation: Yes:1, No:0.

    4. Reasons to donate [6 months]

      investigated reasons why the health care professional´ would donate their organs: To save the life of another person: 1, Because after death the body does not need anything: 2, To create awareness in the donation: 3, For religious reasons: 4, Others: 5

    5. Reasons not to donate [6 months]

      investigated reasons why the health care professional´ would not donate their organs or haven´t decided: for religious aspects: 1, for the improper organs use: 2, to maintain my body integrity: 3, for fear of the removal of organs before my death: 4, for fear that they do not give me the attention Medical needed to save my life: 5, Others: 6

    6. Level of knowledge [6 months]

      investigated how the health care professional would classify the level of knowledge regarding organ donation: Not at all informed: 1, Little informed: 2, Suitably informed: 3

    7. Degree formation [6 months]

      investigated whether the health care professional received organ donation information during their degree formation: Yes:1, No:0.

    8. Post degree formation [6 months]

      investigated whether the health care professional attended to courses on procurement or organ donation after their degree formation: Yes:1, No:0.

    9. Brain death definition [6 months]

      investigated when health care professional consider a neurocritical patient as a potential organ donor: When the patient is in a coma: 1, When brain inactivity is corroborated with technical or instrumental means in a patient with irreversible absence of brain response with loss of consciousness, absence of spontaneous breathing, absence of cephalic reflexes and observation of fixed pupils: 2, When the patient is in a vegetative state: 3, When cardiorespiratory arrest occurs in the patient with irreversible absence of brain response with loss of consciousness, absence of spontaneous breathing, absence of cephalic reflexes and fixation of fixed pupils: 4, Other: 5

    10. Lung organ donor criteria [6 months]

      investigated whether the health care professional know the criteria the organ donor must meet to be considered an optimal lung donor. PaO2 / FiO2> 300 with FiO2 1 and PEEP 10cmH2O, without evidence of aspiration / sepsis, absence of microorganism in sputum / BAL, absence of purulent secretions in tube: 1, X-ray with minimal infiltrates, no evidence of aspiration / sepsis, no history of cardiopulmonary surgery, absence of microorganism in sputum / BAL, absence of secretions: 2, clean chest X-ray, PaO2 / FiO2> 300 with FiO2 1 and PEEP 5cmH2O, absence of thoracic trauma, without evidence of aspiration / sepsis, no history of cardiopulmonary surgery, absence of microorganism in sputum / BAL, absence of purulent secretions in tube: 3, d. Unilateral thoracic trauma, with no evidence of aspiration / sepsis, no history of cardiopulmonary surgery, absence of microorganism in sputum / BAL, absence of purulent secretions in tube: 4

    11. Organ Donor Consent [6 months]

      investigated whether the health care professional knows where and how to express he/she consent for organ donation: Yes:1, No:0.

    12. Potential lung donor management protocols [6 months]

      investigated whether the health care professional knows if the health care institution were he/she works have a potential lung donor management protocol.

    13. Neurocritical patients care [6 months]

      investigated whether the health care professional had ever assist a neurocritical patients during this professional career.

    14. Call to the federal organ procurement organism to report a patients with a GCS ≤ 7 [6 months]

      investigated whether the health care professional had ever call to the federal organ procurement organism (INCUCAI) to report a neurocritical patients with a GCS ≤ 7.

    15. Apnea Test [6 months]

      investigated whether the health care professional had ever done an apnea test during this professional career.

    16. Type of apnea test [6 months]

      investigated which type of apnea test the health care professional had done: the conventional apnea test consisting in preoxygenation and disconnection form the ventilator; or one of the alternative apnea test: by artificial increase of Co2; with CPAP or by controlled hypoventilation.

    17. Call to the federal organ procurement organism to report a possible brain death patient: [6 months]

      investigated whether the health care professional had ever call to the federal organ procurement organism (INCUCAI) to report a possible brain death patient.

    18. Potential organ donor patients care [6 months]

      investigated whether the health care professional had ever participated in the procurement process and maintenance (management) of a potential organ donor patient during this professional career.

    19. Change in ventilator parameters [6 months]

      investigated whether the health care professional make a change in the ventilator parameters after the brain dead diagnosis.

    20. Change in the fraction inspired oxygen [6 months]

      investigated whether the health care professional change the fraction inspired oxygen to 100% after the brain dead diagnosis, or reduced it if the potential lung donor have a PaO2/FiO2 > 300.

    21. Ventilator parameters [6 months]

      investigated which tidal volume (Vt) and positive end expiratory pressure (PEEP) does the health care professional use to ventilate a potential lung donor patient among different options: Vt 10-12 mL/kg, PEEP 5 cmH20:1, Vt 10-12 mL/kg, PEEP 8-10 cmH20:2, Vt 8-10 mL/kg, PEEP 5 cmH20:3, Vt 8-10 mL/kg, PEEP 8-10 cmH20:4, Vt 6-8 mL/kg, PEEP 5 cmH20:5, Vt 6-8 mL/kg, PEEP 8-10cmH20:6, Other:7

    22. Strategies to improve oxygenation [6 months]

      investigated whether the health care professional use any strategy to improve oxygenation in case of low oxygenation and which type of strategies does it use: change positioning:1, pulmonary expansion techniques:2, endotracheal suctioning:3, Fiberoptic bronchoscopy:4, Recruitment maneuvers: 5, PEEP titulation:6, Others:7

    23. Type of Recruitment maneuver [6 months]

      investigated the most commonly used type of recruitment maneuver in a potential PULMONARY donor: Sighs with increased Tidal Volume for several breaths: 1, CPAP of 40 cmH20 for 40 seconds: 2, CPAP of 30 cmH20 for 30 seconds: 3, Step increase of PEEP to 40 cmH20 and then stepwise decrease: 4, PC Mode CMV with inspiratory pressure of 25-30 cmH20 and PEEP 10-15 cmH20 for 2 hours for a single time: 5, PC-CMV mode with inspiratory pressure of 20 cmH20 and stepwise increase of PEEP to 20-30 cmH20: 6, PEEP of 18-20 cmH20 for 1 minute, then decrease PEEP and increase Tidal Volume for several breaths: 7, Other: 8.

    24. Type of PEEP titulation [6 months]

      PEEP / FiO2 Table (ARDS Network): 1, PEEP / Compliance Protocol: 2, Determination of the lower inflection point per Pressure / Volume curve: 3, Increase of the PEEP for Plateau Pressure <28 cmH20 (Express Protocol): 4, Guided by esophageal manometry: 5, Guided by pulmonary ultrasound: 6, Guided by volumetric capnography: 7, Other: 8

    25. Use of a closed-circuit for endotracheal suctioning [6 months]

      investigated whether the health care professional use a closed-circuit for endotracheal suctioning.

    26. Measures to prevent ventilator-associated pneumonia [6 months]

      investigated whether the health care professional consider important to continue the care bundle to prevent ventilator-associated pneumonia such as: head elevation, tracheal cuff control, oral hygiene, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • health care professionals

    • register to the Sociedad Argentina de Terapia Intensiva (SATI)

    • related to the care of neurocritical patients

    • between febrary 16th and september 1st.

    Exclusion Criteria:
    • unrelated to the care of neurocritical patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Italiano de Buenos Aires Buenos Aires Argentina 1414

    Sponsors and Collaborators

    • Hospital Italiano de Buenos Aires

    Investigators

    • Principal Investigator: Vanesa R Ruiz, RT, Hospital Italiano de Buenos Aires

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Hospital Italiano de Buenos Aires
    ClinicalTrials.gov Identifier:
    NCT03458052
    Other Study ID Numbers:
    • 3493
    First Posted:
    Mar 8, 2018
    Last Update Posted:
    Mar 12, 2018
    Last Verified:
    Feb 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital Italiano de Buenos Aires
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 12, 2018