AzTrials
AzTrials

Cardiac ArrestPhase 3FLOWERSNCT01295749

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

A Phase 3 study testing laryngeal tube ventilation and continuous chest compression in people with Cardiac Arrest, run by University Hospital, Grenoble at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
What is being tested?
laryngeal tube ventilation and continuous chest compression
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
2 sitesFrance
Study dates
Mar 2011to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
  • more than 18 years
  • patient affiliated to the social security system or equivalent

Who cannot join

  • certain death
  • patient deprived of freedom by judicial or administrative decision
  • patient under legal protection
  • Pregnancy, parturient or breast feeding
  • facial trauma

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • SDIS

    Fontaine, Isere, 38602

  • Samu Smur

    Grenoble, Isere, 38043

Other trials in France

About this study

Official title: 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.

Read the 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

Conditions
Cardiac Arrest
Being tested
laryngeal tube ventilation and continuous chest compression
Keywords
cardiac arrest, No Flow, Emergency, Nurse, laryngeal Tube
Medical subject headings
Heart Arrest, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laryngeal tube ventilation and continuous chest compressionDevice

    Also called Laryngeal Tube LTD, VBM

    Comparison of no flow time between two strategies in out of hospital cardiac arrest

  • laryngeal tube ventilation and continuous chest compressionDevice

    Also called Laryngeal Tube LTD, VBM

    Comparison of no flow time between two strategies in out of hospital cardiac arrest

Study groups in NCT01295749
Study groupRoleWhat they receive
ventilation by laryngeal tubeActive comparatorventilation by laryngeal tube and continuous chest compression
Receives: Device: laryngeal tube ventilation and continuous chest compression
ventilation by bag valve maskSham comparatorventilation by bag valve mask and interrupted chest compression
Receives: Device: laryngeal tube ventilation and continuous chest compression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: arrival of paramedical staff T0

Secondary outcomes (10)

  1. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    No flow proportion during resuscitation by paramedical staff after emergency training

    Measured: during cardiac arrest at T0

  2. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    no flow proportion on total resuscitation duration

    Measured: during cardiac arrest at T0

  3. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    number of failure installation after 2 tests

    Measured: during cardiac arrest at T0

  4. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Time of device installation

    Measured: during cardiac arrest at T0

  5. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    chest expansion during insuflation (yes/no)

    Measured: during cardiac arrest at T0

  6. 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

    Measured: during cardiac arrest at T0

  7. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    incident during ventilation :

    obstruction number of manipulations to optimize ventilation

    Measured: during cardiac arrest at T0

  8. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    ETCO2

    Measured: during cardiac arrest at T0

  9. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    Number of external electric shocks

    Measured: during cardiac arrest at T0

  10. qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest

    degradation due to technical manipulations

    Measured: during cardiac arrest a T0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionFeb 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01295749
Sponsor's protocol ID
DCIC - 1014
Acronym
FLOWERS
Status last verified
Jul 2012
First submitted
11 Feb 2011
Last updated
3 Jul 2012
Results posted
No
Data monitoring committee
No

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.

    PubMed 16321716

  • 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.

    PubMed 12010909

  • 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.

    PubMed 15210599

  • 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.

    PubMed 17082207

  • 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.

    PubMed 16982127

  • 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.

    PubMed 15687130

  • 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.

    PubMed 18338138

  • 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.

    PubMed 18164533

  • 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.

    PubMed 15657322

  • 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.

    PubMed 15657323

  • 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.

    PubMed 16116053

  • 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.

    PubMed 10078808

  • 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.

    PubMed 11705826

  • 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.

    PubMed 12119255

  • 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.

    PubMed 7618786

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing laryngeal tube ventilation and continuous chest compression in people with Cardiac Arrest, run by University Hospital, Grenoble at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison of no flow time between two strategies (time frame: arrival of paramedical staff T0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01295749, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in