Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia

The objective of this pilot study is provide data for planning and to establish the
feasibility of performing a large, randomized, comparative effectiveness trial of two
specially designed airway tubes (endotracheal tubes; ETTs) for the prevention of
ventilator-associated pneumonia (VAP). Modification of the material and design of the ETT
cuff that is positioned in the trachea, and/or continuous aspiration of subglottic secretions
through an extra port positioned between the tube cuff and the vocal chords may prevent
leakage of contaminated secretions around the cuff and thereby reduce the risk of VAP. The
investigators are planning a phase III, randomized, controlled trial comparing the
effectiveness of a polyurethane-cuffed endotracheal tube (PUC-ETT), a polyurethane-cuffed
tube that also allows continuous aspiration of subglottic secretions (PUC-CASS-ETT), and a
conventional, polyvinylchloride-cuffed endotracheal tube (PVC-ETT) in mechanically ventilated
patients with respiratory failure. Prior to initiating the Phase III trial, a smaller pilot
study is necessary in order to establish feasibility and to gather data on endpoints in order
to establish enrollment rates and project sample size for the definitive trial. For the
purposes of planning, a surrogate for VAP, bacterial colonization of the trachea will be
assessed from daily quantitative cultures to allow estimation of effect size for the two
study devices. VAP will be diagnosed using objective criteria, based on cultures from
bronchoalveolar lavage. The safety profile of the tubes will be evaluated using a
multi-faceted approach, including short-term objective measures of laryngeal dysfunction and
long-term subjective and objective assessment of upper airway problems via phone interview
post-hospital discharge, and recording of device-related adverse events.

Inclusion Criteria:

1. Age 18 years or older;

2. Emergency intubation with a study device either in the field by Medic One, (the
Seattle Fire Department program that provides basic and advanced life support services
to the city) or at HMC;

3. Absence of out-of-hospital cardiac arrest;

4. Absence of major burns, penetrating trauma or absence any major trauma with systolic
blood pressure < 90 mmHg at the time of tracheal intubation.

Exclusion Criteria:

1. Use of a non-study designated intubation device (such as nasal intubation,
tracheostomy, intubation in the operating room, intubation outside the study network
such as occurring in an outside hospital or by other emergency response providers);

2. Patients with permanent tracheostomy;

3. Federally protected populations: Children (age <18 years), pregnant women, and
prisoners.