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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: laryngeal tube ventilation and continuous chest compression

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Isere
    • Fontaine, Isere, France, 38602
      • SDIS
    • Grenoble, Isere, France, 38043
      • Samu Smur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ventilation by laryngeal tube; ventilation by laryngeal tube and continuous chest compression	Device: laryngeal tube ventilation and continuous chest compression; Comparison of no flow time between two strategies in out of hospital cardiac arrest; Other Names: Laryngeal Tube LTD, VBM
Sham Comparator: ventilation by bag valve mask; ventilation by bag valve mask and interrupted chest compression	Device: laryngeal tube ventilation and continuous chest compression; Comparison of no flow time between two strategies in out of hospital cardiac arrest; Other Names: Laryngeal Tube LTD, VBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	Time of device installation	during cardiac arrest at T0
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	chest expansion during insuflation (yes/no)	during cardiac arrest at T0
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
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
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	ETCO2	during cardiac arrest at T0
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	Number of external electric shocks	during cardiac arrest at T0
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest	degradation due to technical manipulations	during cardiac arrest a T0

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Vincent Danel, MD, University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
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• 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.
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• 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.
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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. doi: 10.1093/bja/aem260. Epub 2007 Sep 14.
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Helpful Links

• Nom d'utilisateur : FLOWERS99 mot de passe : FLOWERSTST

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): July 3, 2012
• Last Update Submitted That Met QC Criteria: July 2, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Nurse; cardiac arrest; Emergency; No Flow; laryngeal Tube
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: DCIC - 1014