Intra-Arrest-Ventilation - a Prospective Randomized Trial in Human Cadavers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gerrit Jansen
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Ventilation Pressure with different Airway devices in CCSV
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •> 17 Years of Age
Exclusion Criteria
- •Adult respiratory distress syndrome (ARDS)
- •Severe lung or thoracic injuries
- •pneumothorax
- •Abnormal airways
- •Tracheostoma
- •severe aspirations
Arms & Interventions
Bag-Device-Ventilation
Ventilation with a Ventilation Bag
Intervention: Laryngeal mask (Other)
Bag-Device-Ventilation
Ventilation with a Ventilation Bag
Intervention: I-Gel-Laryngeal Mask (Other)
IPPV
Intermittend-Positive-Pressure-Ventilation
Intervention: Endotracheal Intubation (Other)
IPPV
Intermittend-Positive-Pressure-Ventilation
Intervention: Laryngeal tube (Other)
IPPV
Intermittend-Positive-Pressure-Ventilation
Intervention: Laryngeal mask (Other)
IPPV
Intermittend-Positive-Pressure-Ventilation
Intervention: I-Gel-Laryngeal Mask (Other)
CCSV
Chest Compression Synchronized Ventilation
Intervention: Endotracheal Intubation (Other)
CCSV
Chest Compression Synchronized Ventilation
Intervention: Laryngeal tube (Other)
CCSV
Chest Compression Synchronized Ventilation
Intervention: Laryngeal mask (Other)
CCSV
Chest Compression Synchronized Ventilation
Intervention: I-Gel-Laryngeal Mask (Other)
Bag-Device-Ventilation
Ventilation with a Ventilation Bag
Intervention: Endotracheal Intubation (Other)
Bag-Device-Ventilation
Ventilation with a Ventilation Bag
Intervention: Laryngeal tube (Other)
Outcomes
Primary Outcomes
Ventilation Pressure with different Airway devices in CCSV
Time Frame: After beginning of ventilation up to 4 minutes each device
Expiratory Volume with different Airway Devices in IPPV
Time Frame: After beginning of ventilation up to 4 minutes each device
Mean expiratory Volume with different Airway Devices in IPPV
Secondary Outcomes
No secondary outcomes reported
Investigators
Gerrit Jansen
Principal Investigator
Muehlenkreiskliniken, MKK