Miniature In-line Respirator

Study Description:

Proof of Concept pilot study to support use of a miniature in-line patient respirator for patient ventilation needs.

Objectives:

Primary Objective:

To assess the effectiveness of the miniature respirator to ventilate intubated braindead research donors while maintaining respiratory measures within acceptable range.

Secondary Objective

The miniature respirator performs as designed and tested in a lung simulator.

Endpoints:

Primary Endpoint:

A binary variable equal to 1 ("success") if both of the following criteria are met (during the placement of the test device):

• the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg;

and

• the O(2) saturation measured by pulse oximetry is > 94%.

Otherwise, the primary endpoint is equal to 0 ("failure").

Secondary Endpoints:

Binary variables equal to 1 ("success") if tidal volume and airway pressure settings (PEEP and maximum peak airway pressure) are within 30% of predicted values. Otherwise, the secondary endpoints are equal to 0 ("failure").

• INCLUSION CRITERIA

• Diagnosis of brain death
• Provision of signed and dated informed consent form for organ donation and research by donor family or surrogate decisionmaker.
• Male or female, with no age restriction (see size exclusion).
• Decedent transferred to the Gift of Life at Penn Medicine Donor Care Center (study site) for routine organ donor management and organ recovery procedures.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

• Brain-dead research donor will be excluded if their baseline CO(2) or pulse oximetry is out of the accepted range for the study (defined as end tidal CO(2) between 35- and 45-mm Hg and the O(2) saturation measured by pulse oximetry > 94%) while on optimized ventilation.
• Brain-dead research donors with severe respiratory disease. This may include:

• Bullous lung disease - noted on pre-op imaging or by history.
• h/o pneumothoraces
• h/o severe asthma, COPD, or other significant lung disease
• Brain-dead research donors with morbid obesity (BMI >=40).
• Brain-dead research donor body weight of < 25kg.
• Potential Brain-dead lung transplant donors (as determined by Gift of Life Donor Program staff according to at the time of study site (Donor Care Center) admission)
• Intraoperative arterial blood gas values outside the range of normal for pH, PaO2, PaCO2, HCO3, O2Sat as measured in pre-device ABG (while on optimized ventilation).

Acceptable range for Arterial Blood Gas (ABG values)

Parameter - pH / Range - 7.35-7.45

Parameter - PaO2 / Range - >=75 mm Hg

Parameter - PaCO2 / Range - 35-45 mm Hg

Parameter - HCO3 / Range - 22-26 mEq/L

Parameter - SpO2 / Range - 94-100