Organ Donation Survey Among Health Care Professionals in Argentina

• ClinicalTrials.gov Identifier: NCT03458052
• Recruitment Status: Unknown
• First Posted: March 8, 2018
• Last Update Posted: March 12, 2018
• Sponsor: Hospital Italiano de Buenos Aires
• Information provided by (Responsible Party): Hospital Italiano de Buenos Aires

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
Brain Death; Lung Transplantation; Respiration, Artificial; Tissue and Organ Procurement

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
• Estimated 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: February 16, 2018
• Estimated Primary Completion Date: April 1, 2018
• Estimated Study Completion Date: September 1, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Attitude Toward Organ Donation [ Time Frame: 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 [ Time Frame: 6 months ]
   investigated whether the health care professional is a registered organ donor: Yes:1, No:0.
3. Last will manifest [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
   investigated whether the health care professional received organ donation information during their degree formation: Yes:1, No:0.
8. Post degree formation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    investigated whether the health care professional had ever done an apnea test during this professional career.
16. Type of apnea test [ Time Frame: 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: [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    investigated whether the health care professional use a closed-circuit for endotracheal suctioning.
26. Measures to prevent ventilator-associated pneumonia [ Time Frame: 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

• Ages Eligible for Study: 23 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Heath Care Professionals working in Adult and Pediatric Critical Care Units and Emergency Department from Argentinian Public and Private Hospitals, registrated in the Sociedad Argentina de Terapia Intensiva

Criteria

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

Contacts

Contact: Vanesa R Ruiz, RT; +54(011)4959 0200. ext 5770; vanesa.ruiz@hospitalitaliano.org.ar

Locations

Argentina

Hospital Italiano de Buenos Aires; Recruiting

Buenos Aires, Argentina, 1414

Contact: Vanesa R Ruiz, RT +54(011)4959 0200. ext 5770 vanesa.ruiz@hospitalitaliano.org.ar

Sponsors and Collaborators

Hospital Italiano de Buenos Aires

Investigators

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

More Information

Additional Information:

Alejandro Da Lozzo. Historia del trasplante pulmonar en el mundo y en la Argentina. Rev Hosp Ital. B.Aires 2013;33(3):111-119. 

Ruiz V. R., Da Lozzo A. G., Midley A. D. Optimizaci&#243;n del Soporte Ventilatorio del Donante Pulmonar. Revisi&#243;n Bibliogr&#225;fica. RAMR 2017;2:174-179 

Publications of Results:

Miñambres E, Coll E, Duerto J, Suberviola B, Mons R, Cifrian JM, Ballesteros MA. Effect of an intensive lung donor-management protocol on lung transplantation outcomes. J Heart Lung Transplant. 2014 Feb;33(2):178-84. doi: 10.1016/j.healun.2013.10.034. Epub 2013 Oct 25.

Mascia L, Mastromauro I, Viberti S, Vincenzi M, Zanello M. Management to optimize organ procurement in brain dead donors. Minerva Anestesiol. 2009 Mar;75(3):125-33. Epub 2008 Jan 24. Review.

Valapour M, Paulson K, Smith JM, Hertz MI, Skeans MA, Heubner BM, Edwards LB, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2011 Annual Data Report: lung. Am J Transplant. 2013 Jan;13 Suppl 1:149-77. doi: 10.1111/ajt.12024.

Del Río F, Escudero D, De La Calle B, Vidal FG, Paredes MV, Núñez JR. [Evaluation and maintenance of the lung donor]. Med Intensiva. 2009 Jan-Feb;33(1):40-9. Review. Spanish.

Rosengard BR, Feng S, Alfrey EJ, Zaroff JG, Emond JC, Henry ML, Garrity ER, Roberts JP, Wynn JJ, Metzger RA, Freeman RB, Port FK, Merion RM, Love RB, Busuttil RW, Delmonico FL. Report of the Crystal City meeting to maximize the use of organs recovered from the cadaver donor. Am J Transplant. 2002 Sep;2(8):701-11.

Mascia L, Bosma K, Pasero D, Galli T, Cortese G, Donadio P, Bosco R. Ventilatory and hemodynamic management of potential organ donors: an observational survey. Crit Care Med. 2006 Feb;34(2):321-7; quiz 328.

Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.

Klesney-Tait JA, Eberlein M. Lung protective ventilation in donors: an ounce of prevention. Chest. 2014 Jul;146(1):4-6. doi: 10.1378/chest.14-0163.

McKeown DW, Bonser RS, Kellum JA. Management of the heartbeating brain-dead organ donor. Br J Anaesth. 2012 Jan;108 Suppl 1:i96-107. doi: 10.1093/bja/aer351. Review.

Bansal R, Esan A, Hess D, Angel LF, Levine SM, George T, Raoof S. Mechanical ventilatory support in potential lung donor patients. Chest. 2014 Jul;146(1):220-227. doi: 10.1378/chest.12-2745. Review.

Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. Review. Erratum in: N Engl J Med. 2014 Apr 24;370(17):1668-9.

Munshi L, Keshavjee S, Cypel M. Donor management and lung preservation for lung transplantation. Lancet Respir Med. 2013 Jun;1(4):318-28. doi: 10.1016/S2213-2600(12)70064-4. Epub 2013 Feb 20. Review.

Lucangelo U, Del Sorbo L, Boffini M, Ranieri VM. Protective ventilation for lung transplantation. Curr Opin Anaesthesiol. 2012 Apr;25(2):170-4. doi: 10.1097/ACO.0b013e32834fdb54. Review.

Al-Khafaji A, Murugan R, Kellum JA. What's new in organ donation: better care of the dead for the living. Intensive Care Med. 2013 Nov;39(11):2031-3. doi: 10.1007/s00134-013-3038-1. Epub 2013 Aug 3. Review.

Angel LF, Levine DJ, Restrepo MI, Johnson S, Sako E, Carpenter A, Calhoon J, Cornell JE, Adams SG, Chisholm GB, Nespral J, Roberson A, Levine SM. Impact of a lung transplantation donor-management protocol on lung donation and recipient outcomes. Am J Respir Crit Care Med. 2006 Sep 15;174(6):710-6. Epub 2006 Jun 23.

Kirschbaum CE, Hudson S. Increasing organ yield through a lung management protocol. Prog Transplant. 2010 Mar;20(1):28-32.

Paries M, Boccheciampe N, Raux M, Riou B, Langeron O, Nicolas-Robin A. Benefit of a single recruitment maneuver after an apnea test for the diagnosis of brain death. Crit Care. 2012 Jul 3;16(4):R116. doi: 10.1186/cc11408.

Gabbay E, Williams TJ, Griffiths AP, Macfarlane LM, Kotsimbos TC, Esmore DS, Snell GI. Maximizing the utilization of donor organs offered for lung transplantation. Am J Respir Crit Care Med. 1999 Jul;160(1):265-71.

Noiseux N, Nguyen BK, Marsolais P, Dupont J, Simard L, Houde I, Lallier M, Langevin S, Cantin B, Ferraro P. Pulmonary recruitment protocol for organ donors: a new strategy to improve the rate of lung utilization. Transplant Proc. 2009 Oct;41(8):3284-9. doi: 10.1016/j.transproceed.2009.08.041.

Hanna K, Seder CW, Weinberger JB, Sills PA, Hagan M, Janczyk RJ. Airway pressure release ventilation and successful lung donation. Arch Surg. 2011 Mar;146(3):325-8. doi: 10.1001/archsurg.2011.35.

Philpot SJ, Pilcher DV, Graham SM, Snell GI. Lung recruitment manoeuvres should be considered when assessing suitability for lung donation. Crit Care Resusc. 2012 Sep;14(3):244-5.

Parto S, Shafaghi S, Khoddami-Vishteh HR, Makki SM, Abbasidezfuli A, Daneshvar A, Sheikhy K, Faeghi J, Ghorbani F, Parsa T, Najafizadeh K. Efficacy of recruitment maneuver for improving the brain dead marginal lungs to ideal. Transplant Proc. 2013;45(10):3531-3. doi: 10.1016/j.transproceed.2013.09.001.

• Responsible Party: Hospital Italiano de Buenos Aires
• ClinicalTrials.gov Identifier: NCT03458052
• Other Study ID Numbers: 3493
• First Posted: March 8, 2018
• Last Update Posted: March 12, 2018
• Last Verified: February 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:

Intensive and critical care; Organ donation; Knowledge

Additional relevant MeSH terms:

Brain Death; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes