Endotracheal Tube Clearance Clinical Trial
Official title:
EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS
| Verified date | September 2019 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is designed to compare the effectiveness of a closed suction system with an
inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction
system in terms of reducing the interior resistance of endotracheal tubes. Subjects who
require frequent suctioning ( > every 2.5 hours) and who have stable cardiovascular systems
will be randomized to receive suctioning either through the Cleansweep system or standard
system initially followed by the corresponding system. The subjects will be suctioned every
two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with
the other system). After each suction procedure measurements of resistance will be made using
peak and plateau pressures.
Analysis: For each patient, data for both procedures on each catheter system will be pooled
and mean differences between the standard system and the Cleansweep system will be
calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and
significance will be sought using appropriate statistical tests. The study will be unblinded
and randomization determines merely which system will used initially for the first 2
procedures.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | April 17, 2020 |
| Est. primary completion date | April 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours Exclusion Criteria: - Unstable cardiovascular system (significant arrythmias, blood pressure support requiring > 2 pressors - refractory hypoxemia (P/F ratio < 80) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke Health System | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Teleflex |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures | Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system) | 8 hours |