Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06306898 |
| Other study ID # |
IAV-2024-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 18, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Muehlenkreiskliniken, MKK |
| Contact |
Jansen Gerrit |
| Phone |
004957179054401 |
| Email |
gerrit.jansen[@]muehlenkreiskliniken.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study investigates the influence of non-synchronized bag-device-ventilation and
intermittent positive pressure ventilation (IPPV), as recommended in the current
resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg
body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation
(pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a
sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal
mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation.
Description:
The European Resuscitation Council (ERC) guidelines for cardiopulmonary resuscitation (CPR)
recommend uninterrupted chest compressions and continuous ventilation as soon as a patient is
endotracheally intubated or a supraglottic airway (SGA) is positioned.
Recently, SGAs have been adopted by emergency medical services worldwide as the primary tool
for airway management during CPR. SGAs offer limited protection against aspiration compared
to endotracheal intubation (ETI) and may increase the risk of aspiration. A new ventilation
mode (Chest Compression Synchronized Ventilation [CCSV]) is now available for resuscitation
with uninterrupted chest compressions.
The study investigates the influence of non-synchronized bag-device-ventilation, intermittent
positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines
of the ERC (Vt = 5-6 mL/kg bw, AF = 10 min-1) and CCSV (pInsp = 40 mbar; RR = chest
compression rate) with regard to achieving a sufficient tidal volume and the tightness of
various SGA (laryngeal mask, iGel, laryngeal tube) and endotracheal intubation.
Gender, age, height and weight are documented (external post-mortem examination). The
respective body donor is randomly assigned to a group. The grouping determines the order in
which the means of airway management (SGA, ETI) are used.
Initial airway management is performed with an ETI with blockage of 30 mmH2O). The body donor
is then bronchoscoped. A gastric tube is placed and the pressure probe to be used is
calibrated if necessary. Positive pressure ventilation (pInsp = 40 mbar, positive
end-expiratory pressure (PEEP) = 12 mbar, frequency = 10 min-1) is performed for 2 minutes to
recruit the lungs. Vt is documented.
Mechanical cardiopulmonary resuscitation (CPR) is then performed for minutes (4 cycles) using
the mechanical chest compression device in accordance with ERC 2015. Ventilation pressure and
flow curves are continuously recorded by the respirator (Medumat Standard², Weinmann GmbH).
Leaks are detected via the automatically initiated ventilation curves, measured and recorded
by the ventilator. Ventilation takes place for 4 minutes with bad-device-ventilation, 4
minutes in IPPV mode and 4 minutes in CCSV mode. At the end of the two cycles, the body donor
is intubated with one of the remaining airway devices, and the lungs are recruited again and
mechanical CPR is performed again for 12 minutes using the 3 ventilation modes.
