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NASG for Relief Settings. Consultation on Reproductive Health Technologies for Crises Settings PATH & Women's Commission for Refugee Women and Children May 13-14, 2008 Suellen Miller, CNM, PhD Associate PRofessor UCSF, Dept Ob/Gyn & Reproductive Sciences. Pneumatic AntiShock Garment . PASG.
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NASG for Relief Settings Consultation on Reproductive Health Technologies for Crises Settings PATH & Women's Commission for Refugee Women and Children May 13-14, 2008 Suellen Miller, CNM, PhD Associate PRofessor UCSF, Dept Ob/Gyn & Reproductive Sciences
PASG • Did not make statistically significant difference in mortality and morbidity for lower body trauma patients (all ages, all dxs.) in urban settings with trauma centers • Use of PASG for obstetrical hemorrhage: • ONLY 6 cases reported • NO comparative trials
NASG • Light-weight, reusable • Lower body counter pressure • Decreases bleeding • Reverses shock • May contribute to decreased morbidity and mortality
3 way stretch neoprene (wet suit material) Industrial strength Velcro Foam pressure ball over uterus
THERAPEUTIC EFFECTS OF ANTISHOCK GARMENT • Efficient, simple & safe circumferential counterpressure RESUSCITATION OF CENTRAL CIRCULATION • Results in translocation of up to 30% of total blood volume from lower body to core REDUCES HEMORRHAGE IN LOWER BODY • Decrease in arterial perfusion pressure to the uterus, comparable to ligation of the internal iliac arteries. • Overcomes pressure in capillary and venous system (15-25 mm Hg.), reduction of transmural pressure, vessel radius and flow.
USES • Stabilizes patient while evaluating, transporting, or preparing for definitive surgical treatment. • Can be safely and comfortably used up to 48 hours. • May arrest bleeding and avoid surgical intervention. • May decrease need for or number of blood transfusions • During delays, such as waiting for interventional radiology
Obstetric Hemorrhage NASG
What NASG Does NOT DO Does not avert the necessity for evaluation • to identify cause of shock • to manage fluid and blood replacement • to provide appropriate therapy for coagulopathy
Little Experience with NASG • 206: Egypt (results published) • Results being analyzed • 540: Egypt II • 580: Nigeria • 1126 women treated with the NASG to date
Egypt: 364 Women • 50% lower median measured blood loss in the drape, 68% decrease in morbidity and mortality
Median Pulse Recovery Times from Kaplan-Meier Survival Analysis * Log Rank Test adjusted for pulse at admission = 21.20, p=0.000
Findings Promising • Clinically promising: faster recovery, shorter time of oxygen deprivation, lower blood loss THAN standard treatment • Statistically significant on PROXY indicators • OUTCOMES OF INTEREST: Mortality and Morbidity, not statistically significant • Lower quality design, PRE/POST
Lack of Evidence for Crisis Settings • To date, these results have all been obtained at tertiary care facilities with access to surgery, blood and sufficient supplies, anesthesiologists, etc. • Currently testing whether application at a clinic prior to transfer will affect outcomes
Applicability for Relief Settings • Easy to use • Training for application, management and removal just a few hours • Can stabilize patients for transport to a referral facility
Barriers to Use in Relief Settings • Institutional capacity(tested in tertiary centers) • NASG is first aid - not definitive treatment • Facilities must be able to provide • Oxygen • Normal Saline • Blood • Uterotonics and other medicines • Surgery/anesthesia • NASG buys time, but patients still need to be monitored, so adequate staffing, essential drugs and equipment are important • Provider training and retraining is required, new staff must constantly be trained
Barriers cont. • Referral protocols • Referral hospitals that will receive referred patients must first be trained and proficient • Patients need to be sent to the correct facility • If referral protocol is not correctly implemented, the patient’s greatest risk is improper removal of the NASG by untrained staff • Protocols for garment cleaning and return or exchange need to be established
Barriers cont. • Community acceptance • Patient compliance varies by site • Patient education for life-threatening situations is difficult and problematic
Barriers cont. • Care and maintenance • Highly correlated with the lifespan of the NASG • Adequate supply of clean water required • Not difficult, but must be done properly; not intuitive, needs training, re-training and support • Cleaning staff need to be trained to properly clean, fold, and store • Time lost due to clean ones not available • Time lost due to improper folding
NIH/GATES Collaboration: UCSF, WHO/RHR, CREP, UTH, UZ • Randomized Cluster Trial • Zambia and Zimbabwe • Standard Treatment (uterotonics/IVs) and Application of NASG at midwifery-led peripheral clinics or Standard Treatment • Transport to Tertiary Care Hospital where all women receive NASG • Sample size large enough to demonstrate 50% decrease in M&M
Brees C, Hensleigh PA, Miller S, Pelligra R. (2004). A non-inflatable anti shock garment for obstetric hemorrhage. Int J Gynaecol Obstet, 87 (2), 119-124, 2004. • *Miller, S, Hamza, S, Bray E, Gipson R, Nada, K, Fathalla, M, Mourad, M. et al. First Aid for Obstetrical Hemorrhage: The Pilot Study of the Non-pneumatic Anti-Shock Garment (NASG) in Egypt. British Journal of Obstet Gynaecol, 113(4): p. 424-9, 2006. • Miller, S., Turan, JM, Ojengbede A, Ojengbede, O, Fathalla, M, Morhason-Bello, IO, Mourad, M, Galandanci, H, Hamza, S, Awaal, M, Akinwuntan, A, Mohammed AI, McDonough, L, Dau, K, Butrick, E, and Hensleigh, P. The Pilot Study of the Non-pneumatic Anti-Shock Garment (NASG) in Women with Severe Obstetric Hemorrhage: Combined Results from Egypt and Nigeria. Int J Gynaecol Obstet, 94(S3), ps43-s44. 2006 • * Miller, S & Hensleigh, P. Non-pneumatic Anti-shock Garment for Obstetric Hemorrhage.Book Chapter, in International Federation of Obstetrics and Gynecology (FIGO) Book, Postpartum Hemorrhage: New Thoughts, New Approaches, Editors: C. B-lynch, A. LaLonde, L. West,. Sapiens Publications, UK. 2006 • * Miller, S, Ojengbede A, Turan J, Ojengbede O, Butrick E, Hensleigh, P. Anti-Shock Garments for Obstetric Hemorrhage. Current Women’s Health Reviews, 3(1), 3-11, 2006. • * Miller, S, Turan, JM, Dau, K, Fathalla M, Mourad M, Sutherland, T, Hamza, S. et al. Decreasing Maternal Mortality from Hypovolemic Shock in Low Resource Settings: the Non-pneumatic Anti-Shock Garment (NASG). Global Public Health Journal, 2(2);110-24, 2006.
Thank you….. • Questions???