Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2. juli 2012 opdateret af: University Hospital, Grenoble
Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.
International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.
In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Multicentric, prospective, controlled, randomized study with parallel groups in single blind.
Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.
Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.
The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :
A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Isere
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Fontaine, Isere, Frankrig, 38602
- SDIS
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Grenoble, Isere, Frankrig, 38043
- Samu Smur
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
- more than 18 years
- patient affiliated to the social security system or equivalent
Exclusion Criteria:
- certain death
- patient deprived of freedom by judicial or administrative decision
- patient under legal protection
- Pregnancy, parturient or breast feeding
- facial trauma
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
|
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Andre navne:
|
|
Sham-komparator: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
|
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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comparison of no flow time between two strategies
Tidsramme: arrival of paramedical staff T0
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group A : ventilation by bag valve mask and interrupted chest compression group B : ventilation by laryngeal tube and continuous chest compression outcome measure : time of no flow during Resuscitation by trained paramedical staff in out of hospital cardiac arrest |
arrival of paramedical staff T0
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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No flow proportion during resuscitation by paramedical staff after emergency training
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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no flow proportion on total resuscitation duration
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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number of failure installation after 2 tests
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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Time of device installation
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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chest expansion during insuflation (yes/no)
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive
|
during cardiac arrest at T0
|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
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incident during ventilation : obstruction number of manipulations to optimize ventilation |
during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
ETCO2
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
Number of external electric shocks
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest a T0
|
degradation due to technical manipulations
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during cardiac arrest a T0
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Vincent Danel, MD, University Hospital, Grenoble
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Nolan JP, Deakin CD, Soar J, Bottiger BW, Smith G; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. doi: 10.1016/j.resuscitation.2005.10.009. No abstract available.
- Eftestol T, Wik L, Sunde K, Steen PA. Effects of cardiopulmonary resuscitation on predictors of ventricular fibrillation defibrillation success during out-of-hospital cardiac arrest. Circulation. 2004 Jul 6;110(1):10-5. doi: 10.1161/01.CIR.0000133323.15565.75. Epub 2004 Jun 21.
- Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med. 2001 Jan;37(1):32-7. doi: 10.1067/mem.2001.112098.
- Eftestol T, Sunde K, Steen PA. Effects of interrupting precordial compressions on the calculated probability of defibrillation success during out-of-hospital cardiac arrest. Circulation. 2002 May 14;105(19):2270-3. doi: 10.1161/01.cir.0000016362.42586.fe.
- Adrie C, Cariou A, Mourvillier B, Laurent I, Dabbane H, Hantala F, Rhaoui A, Thuong M, Monchi M. Predicting survival with good neurological recovery at hospital admission after successful resuscitation of out-of-hospital cardiac arrest: the OHCA score. Eur Heart J. 2006 Dec;27(23):2840-5. doi: 10.1093/eurheartj/ehl335. Epub 2006 Nov 2. Erratum In: Eur Heart J. 2007 Mar;28(6):774.
- Edelson DP, Abella BS, Kramer-Johansen J, Wik L, Myklebust H, Barry AM, Merchant RM, Hoek TL, Steen PA, Becker LB. Effects of compression depth and pre-shock pauses predict defibrillation failure during cardiac arrest. Resuscitation. 2006 Nov;71(2):137-45. doi: 10.1016/j.resuscitation.2006.04.008. Epub 2006 Sep 18.
- Abella BS, Sandbo N, Vassilatos P, Alvarado JP, O'Hearn N, Wigder HN, Hoffman P, Tynus K, Vanden Hoek TL, Becker LB. Chest compression rates during cardiopulmonary resuscitation are suboptimal: a prospective study during in-hospital cardiac arrest. Circulation. 2005 Feb 1;111(4):428-34. doi: 10.1161/01.CIR.0000153811.84257.59.
- Wiese CH, Bahr J, Bergmann A, Bergmann I, Bartels U, Graf BM. [Reduction in no flow time using a laryngeal tube: comparison to bag-mask ventilation]. Anaesthesist. 2008 Jun;57(6):589-96. doi: 10.1007/s00101-008-1358-2. German.
- Odegaard S, Pillgram M, Berg NE, Olasveengen T, Kramer-Johansen J. Time used for ventilation in two-rescuer CPR with a bag-valve-mask device during out-of-hospital cardiac arrest. Resuscitation. 2008 Apr;77(1):57-62. doi: 10.1016/j.resuscitation.2007.11.005.
- Wik L, Kramer-Johansen J, Myklebust H, Sorebo H, Svensson L, Fellows B, Steen PA. Quality of cardiopulmonary resuscitation during out-of-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):299-304. doi: 10.1001/jama.293.3.299.
- Abella BS, Alvarado JP, Myklebust H, Edelson DP, Barry A, O'Hearn N, Vanden Hoek TL, Becker LB. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):305-10. doi: 10.1001/jama.293.3.305.
- Valenzuela TD, Kern KB, Clark LL, Berg RA, Berg MD, Berg DD, Hilwig RW, Otto CW, Newburn D, Ewy GA. Interruptions of chest compressions during emergency medical systems resuscitation. Circulation. 2005 Aug 30;112(9):1259-65. doi: 10.1161/CIRCULATIONAHA.105.537282. Epub 2005 Aug 22.
- Kern KB, Hilwig RW, Berg RA, Ewy GA. Efficacy of chest compression-only BLS CPR in the presence of an occluded airway. Resuscitation. 1998 Dec;39(3):179-88. doi: 10.1016/s0300-9572(98)00141-5.
- Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70. doi: 10.1161/hc4501.098926.
- Yu T, Weil MH, Tang W, Sun S, Klouche K, Povoas H, Bisera J. Adverse outcomes of interrupted precordial compression during automated defibrillation. Circulation. 2002 Jul 16;106(3):368-72. doi: 10.1161/01.cir.0000021429.22005.2e.
- Bowman FP, Menegazzi JJ, Check BD, Duckett TM. Lower esophageal sphincter pressure during prolonged cardiac arrest and resuscitation. Ann Emerg Med. 1995 Aug;26(2):216-9. doi: 10.1016/s0196-0644(95)70154-0.
- Gabrielli A, Wenzel V, Layon AJ, von Goedecke A, Verne NG, Idris AH. Lower esophageal sphincter pressure measurement during cardiac arrest in humans: potential implications for ventilation of the unprotected airway. Anesthesiology. 2005 Oct;103(4):897-9. doi: 10.1097/00000542-200510000-00031. No abstract available.
- Wenzel V, Idris AH, Banner MJ, Kubilis PS, Williams JL Jr. Influence of tidal volume on the distribution of gas between the lungs and stomach in the nonintubated patient receiving positive-pressure ventilation. Crit Care Med. 1998 Feb;26(2):364-8. doi: 10.1097/00003246-199802000-00042.
- Wenzel V, Idris AH, Banner MJ, Kubilis PS, Band R, Williams JL Jr, Lindner KH. Respiratory system compliance decreases after cardiopulmonary resuscitation and stomach inflation: impact of large and small tidal volumes on calculated peak airway pressure. Resuscitation. 1998 Aug;38(2):113-8. doi: 10.1016/s0300-9572(98)00095-1.
- Lawes EG, Baskett PJ. Pulmonary aspiration during unsuccessful cardiopulmonary resuscitation. Intensive Care Med. 1987;13(6):379-82. doi: 10.1007/BF00257678.
- Sayre MR, Sakles JC, Mistler AF, Evans JL, Kramer AT, Pancioli AM. Field trial of endotracheal intubation by basic EMTs. Ann Emerg Med. 1998 Feb;31(2):228-33.
- Bradley JS, Billows GL, Olinger ML, Boha SP, Cordell WH, Nelson DR. Prehospital oral endotracheal intubation by rural basic emergency medical technicians. Ann Emerg Med. 1998 Jul;32(1):26-32. doi: 10.1016/s0196-0644(98)70095-2.
- Dorges V, Wenzel V, Schumann T, Neubert E, Ocker H, Gerlach K. Intubating laryngeal mask airway, laryngeal tube, 1100 ml self-inflating bag-alternatives for basic life support? Resuscitation. 2001 Nov;51(2):185-91. doi: 10.1016/s0300-9572(01)00423-3.
- Ocker H, Wenzel V, Schmucker P, Steinfath M, Dorges V. A comparison of the laryngeal tube with the laryngeal mask airway during routine surgical procedures. Anesth Analg. 2002 Oct;95(4):1094-7, table of contents. doi: 10.1097/00000539-200210000-00057.
- Bein B, Carstensen S, Gleim M, Claus L, Tonner PH, Steinfath M, Scholz J, Dorges V. A comparison of the proseal laryngeal mask airway, the laryngeal tube S and the oesophageal-tracheal combitube during routine surgical procedures. Eur J Anaesthesiol. 2005 May;22(5):341-6. doi: 10.1017/s026502150500058x.
- Genzwuerker HV, Finteis T, Slabschi D, Groeschel J, Ellinger K. Assessment of the use of the laryngeal tube for cardiopulmonary resuscitation in a manikin. Resuscitation. 2001 Dec;51(3):291-6. doi: 10.1016/s0300-9572(01)00410-5.
- Figueredo E, Martinez M, Pintanel T. A comparison of the ProSeal laryngeal mask and the laryngeal tube in spontaneously breathing anesthetized patients. Anesth Analg. 2003 Feb;96(2):600-5, table of contents. doi: 10.1097/00000539-200302000-00054.
- Mihai R, Knottenbelt G, Cook TM. Evaluation of the revised laryngeal tube suction: the laryngeal tube suction II in 100 patients. Br J Anaesth. 2007 Nov;99(5):734-9. doi: 10.1093/bja/aem260. Epub 2007 Sep 14.
- Genzwuerker HV, Dhonau S, Ellinger K. Use of the laryngeal tube for out-of-hospital resuscitation. Resuscitation. 2002 Feb;52(2):221-4. doi: 10.1016/s0300-9572(01)00472-5.
- Kette F, Reffo I, Giordani G, Buzzi F, Borean V, Cimarosti R, Codiglia A, Hattinger C, Mongiat A, Tararan S. The use of laryngeal tube by nurses in out-of-hospital emergencies: preliminary experience. Resuscitation. 2005 Jul;66(1):21-5. doi: 10.1016/j.resuscitation.2004.12.023.
- Dorges V, Ocker H, Wenzel V, Sauer C, Schmucker P. Emergency airway management by non-anaesthesia house officers--a comparison of three strategies. Emerg Med J. 2001 Mar;18(2):90-4. doi: 10.1136/emj.18.2.90.
- Dorges V, Wenzel V, Neubert E, Schmucker P. Emergency airway management by intensive care unit nurses with the intubating laryngeal mask airway and the laryngeal tube. Crit Care. 2000;4(6):369-76. doi: 10.1186/cc720. Epub 2000 Oct 13.
- Asai T, Hidaka I, Kawachi S. Efficacy of the laryngeal tube by inexperienced personnel. Resuscitation. 2002 Nov;55(2):171-5. doi: 10.1016/s0300-9572(02)00170-3.
- Asai T, Kawachi S. Use of the laryngeal tube by paramedic staff. Anaesthesia. 2004 Apr;59(4):408-9. doi: 10.1111/j.1365-2044.2004.03721.x. No abstract available.
- Kurola J, Harve H, Kettunen T, Laakso JP, Gorski J, Paakkonen H, Silfvast T. Airway management in cardiac arrest--comparison of the laryngeal tube, tracheal intubation and bag-valve mask ventilation in emergency medical training. Resuscitation. 2004 May;61(2):149-53. doi: 10.1016/j.resuscitation.2004.01.014.
- Kurola JO, Turunen MJ, Laakso JP, Gorski JT, Paakkonen HJ, Silfvast TO. A comparison of the laryngeal tube and bag-valve mask ventilation by emergency medical technicians: a feasibility study in anesthetized patients. Anesth Analg. 2005 Nov;101(5):1477-1481. doi: 10.1213/01.ANE.0000182330.54814.70.
- Wiese CH, Bartels U, Schultens A, Steffen T, Torney A, Bahr J, Graf BM. Influence of airway management strategy on "no-flow-time" during an "advanced life support course" for intensive care nurses - a single rescuer resuscitation manikin study. BMC Emerg Med. 2008 Apr 10;8:4. doi: 10.1186/1471-227X-8-4.
- Gueugniaud PY, David JS, Chanzy E, Hubert H, Dubien PY, Mauriaucourt P, Braganca C, Billeres X, Clotteau-Lambert MP, Fuster P, Thiercelin D, Debaty G, Ricard-Hibon A, Roux P, Espesson C, Querellou E, Ducros L, Ecollan P, Halbout L, Savary D, Guillaumee F, Maupoint R, Capelle P, Bracq C, Dreyfus P, Nouguier P, Gache A, Meurisse C, Boulanger B, Lae C, Metzger J, Raphael V, Beruben A, Wenzel V, Guinhouya C, Vilhelm C, Marret E. Vasopressin and epinephrine vs. epinephrine alone in cardiopulmonary resuscitation. N Engl J Med. 2008 Jul 3;359(1):21-30. doi: 10.1056/NEJMoa0706873.
- Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C, Vergnion M, Petit P, Carli P. A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group. N Engl J Med. 1998 Nov 26;339(22):1595-601. doi: 10.1056/NEJM199811263392204.
- Asai T, Moriyama S, Nishita Y, Kawachi S. Use of the laryngeal tube during cardiopulmonary resuscitation by paramedical staff. Anaesthesia. 2003 Apr;58(4):393-4. doi: 10.1046/j.1365-2044.2003.03095_15.x. No abstract available.
- Asai T, Shingu K. The laryngeal tube. Br J Anaesth. 2005 Dec;95(6):729-36. doi: 10.1093/bja/aei269.
- Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett P, Becker L, Bossaert L, Delooz H, Dick W, Eisenberg M, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. Task Force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Ann Emerg Med. 1991 Aug;20(8):861-74. No abstract available.
- Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M; ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient. The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med. 2005 Mar;31(3):476-9. doi: 10.1007/s00134-005-2574-8. Epub 2005 Feb 15. No abstract available.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2011
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
11. februar 2011
Først indsendt, der opfyldte QC-kriterier
11. februar 2011
Først opslået (Skøn)
14. februar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DCIC - 1014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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