Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— FLOWERS  

Official title:

Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295749
• Other study ID #: DCIC - 1014
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2011
• Last updated: July 2, 2012
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• laryngeal tube ventilation and continuous chest compression
Comparison of no flow time between two strategies in out of hospital cardiac arrest
• laryngeal tube ventilation and continuous chest compression
Comparison of no flow time between two strategies in out of hospital cardiac arrest

Locations

Country	Name	City	State
France	SDIS	Fontaine	Isere
France	Samu Smur	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (43)

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Figueredo E, Martínez 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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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):1477-81. — View Citation

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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. Epub 2007 Sep 14. — View Citation

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Ocker H, Wenzel V, Schmucker P, Steinfath M, Dörges 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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of no flow time between two strategies	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	Yes
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	No flow proportion during resuscitation by paramedical staff after emergency training	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	no flow proportion on total resuscitation duration	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	number of failure installation after 2 tests	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	Time of device installation	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	chest expansion during insuflation (yes/no)	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	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	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	incident during ventilation : obstruction number of manipulations to optimize ventilation	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	ETCO2	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	Number of external electric shocks	during cardiac arrest at T0	No
Secondary	qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	degradation due to technical manipulations	during cardiac arrest a T0	No

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