The use of the laryngeal tube versus the endotracheal tube in out-of hospital cardiac arrest and their effects on arterial blood gas analysis

ISRCTN ISRCTN54937993
DOI https://doi.org/10.1186/ISRCTN54937993
Secondary identifying numbers V1.0
Submission date
21/06/2014
Registration date
09/09/2014
Last edited
08/12/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims?
Cardiac arrest happens when the heart suddenly stops pumping blood around the body. This is a medical emergency as damage to the brain and other organs can lead to death very soon afterwards. The brain is particularly sensitive to a lack of oxygen with brain cells beginning to die after about 4 minutes. There is an ongoing discussion as to which kind of airway device used during resuscitation attempts in patients having a cardiac arrest outside of hospital (out-of hospital cardiac arrest) is most likely to result in survival of the patient and with minimal/no damage to the brain. The endotracheal tube (a tube inserted into the windpipe though the mouth or nose) is still considered the “gold standard” method of securing an airway and therefore delivering oxygen to the body in cases of cardiac arrest. However, there are also several supraglottic airway devices (breathing devices that sit on the larynx or voice box) available. The laryngeal tube in particular is now widely used. Some studies suggest that the laryngeal tube and other supraglottic airway devices may not be as successful as the endotracheal tube in preventing brain damage after an out-of hospital cardiac arrest. Here, we will compare the performance of the endotracheal tube and laryngeal tube during after an out-of hospital cardiac arrest. This will be done by analysing the amount of oxygen in the blood during resuscitation and also once the resuscitation is successful (that is when the patient’s heart begins to beat normally and they start breathing again).

Who can take part?
Adult patients with an age of over 18 years, suffering from out-of hospital cardiac arrest. Cardiac arrest should be witnessed and of presumed cardiac origin (determined by the emergency physician).

What does the study involve?
Patients suffering from an out-of hospital cardiac arrest are randomly allocated to one of two groups. Those in group 1 are treated using the laryngeal tube. Those in group 2 are treated using the endotracheal tube. Ten minutes after the airway has been secured a sample of blood from an artery is taken to measure the amount of gas (for example oxygen) it contains. Once the patient has been admitted to hospital, another blood sample is taken to see whether there are any changes to the arterial blood gases depending on the airway device used.

What are the possible benefits and risks of participating?
We expect no extraordinary risk to the patient. The arterial puncture procedure used to collect the blood sample is performed in every patient in a critical condition when arriving the emergency department.

Where is this study run from?
Department of Emergency Medicine of the Medical University of Vienna (Austria)

When is the study starting and how long is it expected to run for?
January 2015 to December 2015

Who is funding the study?
The Medical University of Vienna (Austria)

Who is the main contact?
Dr. Raphael van Tulder
mailto:raphael.van-tulder@meduniwien.ac.at

Contact information

Dr Raphael van Tulder
Scientific

Department of Emergency Medicine
Medical University of Vienna
Waehringerguertel 18-20
Vienna
AT-1090
Austria

Phone +43 (0) 1 40400 1964
Email raphael.van-tulder@meduniwien.ac.at

Study information

Study designThe study is planned in a prospective, randomized-controlled setting.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet N/A
Scientific titleThe use of the laryngeal tube versus the endotracheal tube in out-of hospital cardiac arrest and their effects on arterial blood gas analysis: a randomized, controlled trial
Study acronymThe TUTORIAL Trial
Study objectivesThe use of the LT influences ventilation outcomes compared to conventional ET.
Ethics approval(s)Ethical committee of the Medical University of Vienna, 06/06/2014, ref. 1313/2014
Health condition(s) or problem(s) studiedCardiopulmonary resuscitation, airway management
InterventionPatients will receive either:
1. Intubation with laryngeal tube
2. Intubation with endotracheal tube
after cardiac arrest.
Intervention typeOther
Primary outcome measurePrimary outcome is defined as arterial pCO2 measured within 10 minutes of establishing the secure airway
Secondary outcome measures1. Any ROSC (only brief signs of circulation of less than 20 minutes, making chest compressions unnecessary)
2. Sustained ROSC (signs of circulation persist for more than 20 minutes, making chest compressions unnecessary)
3. EtCO2 continuously measured by the Lifepak 12/15 Monitor (mean value of all measurements until hospital admission, and mean value in the first 10 minutes after inclusion)
4. Quality of CPR: hands-off times
5. Time needed for airway management
6. Intubation attempts
7. Arterial blood gas analysis within 10 minutes (except apCO2, because primary outcome parameter) and on admission (pH, paCO2, pO2, lactate, BE)
8. EtCO2 on arrival
9. ΔetCO2 compared between first measured value and etCO2 on admission
10. changes values of blood gas analysis measurements (ΔpH, ΔpCO2, ΔpO2, Δlactate, ΔBE) between first measurement on-scene and first measurement at hospital admission
11. Rates of Aspiration revealed by Chest-X-ray after admission
12. 30-days survival
13. 6- months survival
14. Neurological outcome after 6 months, favorable outcome defined as CPC 1 or 2, non-favorable outcome defined as CPS >2 or deceased within 6 months.
Overall study start date01/01/2015
Completion date31/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1400
Key inclusion criteria1. Adult patients with an age of >18 years
2. Patients with witnessed OHCA of presumed cardiac origin (determined by the emergency physician)
3. Cardiac arrest patients with ongoing chest compression cardiopulmonary resuscitation
Key exclusion criteria1. Standardized Lund University Cardiac Arrest System (LUCAS, Physiocontrol, 22370 Lund Sweden) mechanical chest compressions not applied before randomization
2. Traumatic OHCA:
2.1. Cardiac arrest due to exsanguination, strangulation, hanging or drowning
2.2. Cardiac arrest due to presumed intracranial hemorrhage
2.3. Cardiac arrest due to respiratory failure
2.4. Patients with an Allow-natural-death- (AND) or Do-not-attempt-resuscitation (DNAR) order or patients with a terminal illness
2.5 Known or clinically apparent pregnancy
2.6. Airway device has been introduced before the emergency physician has arrived at the scene
2.7 Already established tracheostomy e.g. coniotomy
2.8. Upper airway obstruction due to a foreign body or massive pharyngeal swelling e.g. edema for example due to an allergic reaction
2.9. Ward of the state / prisoner
Date of first enrolment01/01/2015
Date of final enrolment31/12/2015

Locations

Countries of recruitment

  • Austria

Study participating centre

Department of Emergency Medicine
Vienna
AT-1090
Austria

Sponsor information

Medical University of Vienna (Austria)
University/education

Waehringerguertel 18-20/6D
Vienna
AT-1090
Austria

Phone +43 (0) 1 40400 1964
Email anton.laggner@meduniwien.ac.at
Website http://www.meduniwien.ac.at/notfall
ROR logo "ROR" https://ror.org/05n3x4p02

Funders

Funder type

University/education

Medical University of Vienna (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

08/12/2016: Internal review.