Ventilator-acquired Pneumonia
Conditions
Keywords
pneumonia, endotracheal intubation
Brief summary
Researchers are looking at three different types of breathing tubes to see if any of them are better at preventing pneumonia than the others. Two of the tubes have design features to prevent leakage of fluids from the mouth and throat into the lungs. This is importance, since leakage of small amounts of fluid into the lungs may lead to pneumonia. The third tube is the standard tube used at most hospitals. The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs will reduce the risk of developing pneumonia, compared to the standard tube. The study will also look at the safety of the modified breathing tubes, compared to the standard tube. This study is a small, pilot study that will determine if it is possible to perform a larger study that will provide more certain results.
Detailed description
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.
Interventions
DEVICEPVC ETT
Placement of a PVC-cuffed ETT in the setting of emergent intubation.
DEVICEPUC ETT
Placement of a PUC-cuffed ETT in the setting of emergent intubation.
DEVICEPUC-CASS ETT
Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Tracheal Bacterial Colonization | Tracheal colonization by Day 4 or extubation | The percentage of patients with quantitative culture growth from tracheal aspirate specimens of \>1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms. |
Countries
United States
Participant flow
Recruitment details
Patients undergoing emergency tracheal intubation. EMS routed Harborview Medical Center (HMC) or patients who required emergent tracheal intubation while in HMC.
Participants by arm
| Arm | Count |
|---|---|
| PVC ETT Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation. | 36 |
| PUC ETT Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation. | 32 |
| PUC-CASS ETT Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation. | 34 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 9 | 4 | 11 |
| Overall Study | Lost to Follow-up | 8 | 9 | 11 |
| Overall Study | No ICU Admit | 5 | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 2 | 1 |
| Overall Study | Routed to OSH | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 2 |
Baseline characteristics
| Characteristic | PVC ETT | PUC ETT | PUC-CASS ETT | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 7 Participants | 6 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 25 Participants | 28 Participants | 75 Participants |
| Region of Enrollment United States | 36 participants | 32 participants | 34 participants | 102 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 24 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 36 | 1 / 32 | 0 / 34 |
| serious Total, serious adverse events | 9 / 36 | 5 / 32 | 9 / 34 |
Outcome results
Primary
Percentage of Patients With Tracheal Bacterial Colonization
The percentage of patients with quantitative culture growth from tracheal aspirate specimens of \>1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.
Time frame: Tracheal colonization by Day 4 or extubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PVC ETT | Percentage of Patients With Tracheal Bacterial Colonization | 8 percentage of tracheal colonization |
| PUC ETT | Percentage of Patients With Tracheal Bacterial Colonization | 7 percentage of tracheal colonization |
| PUC-CASS ETT | Percentage of Patients With Tracheal Bacterial Colonization | 9 percentage of tracheal colonization |