Ineffective Airway Clearance Clinical Trial
Official title:
Test of a Novel Visual Sputum Suctioning System in Mechanically Ventilated Patients
BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter
(visual sputum suctioning system or VSSS), which the investigators previously tested in
vitro and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen
catheter.
PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum
suctioning system in mechanical ventilated patients in respiratory intensive care unit
(RICU). The investigators compare the weight of secretions collected, vital signs, and
tracheal wall injury between two groups of patients randomized to have VSSS combined with
closed system suction (CSC) suction and patients having CSC suction alone.
HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less
change of vital signs than conventional CSC.
Study design: This is a randomized controlled trial study, including patients ventilated in
one respiratory intensive care unit (RICU). Two suction systems (The novel VSSS and
conventional CSS alone) will be compared at time point before (baseline), immediately after,
3 min after, and 5 min after suctioning.
Background: Sputum suctioning is a routine clinical procedure that is crucial for keeping
the airway open, to reduce the incidence of respiratory-tract infections. In most
circumstances, a conventional catheter with a single-lumen channel is used for sputum
suctioning. However, this procedure Involves blind manipulation of the catheter on the part
of the clinician and thus depends largely on the clinician's skills and experience.
Therefore, complications occur in some patients, especially on the changes of the parameters
of the heart-lung system. In addition, because clinicians cannot directly target sputum in
the trachea, the efficiency of the procedure may be reduced.
Recently, a visual sputum suctioning system (VSSS) was developed in our research group. It
integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.
In vitro tests investigators found that the ability to visualize the airway allows targeting
of sputum, which compensates for the smaller lumen and makes the suctioning procedure more
efficient overall. In addition, in animal tests investigators found that the VSSS collected
more sputum and caused less tracheal mucosa damage than conventional suctioning.
Purpose: The present study investigated the safety and efficacy of sputum suctioning system
with this double-lumen catheter in mechanical ventilated patients in respiratory intensive
care unit (RICU). The purpose of this study was to compare the weight of secretions
collected, vital signs, and tracheal wall injury between two groups of patients randomized
to have VSSS combined with closed system suction (CSC) suction and patients having CSC
suction alone. investigators theorized that the VSSS collected more sputum and caused less
change of vital signs than conventional CSC.
Registry procedure: All requested information will be recorded on case report forms and
explanation will be reported for any missing data. False data will be clearly corrected, and
signed by investigator or authorized person.
Monitoring will be realized by the co-investigator in association with the clinical research
associate.
Sample size assessment: Number of subjects: 40 patients. Three months should be necessary to
include these patients.
Statistical analysis: Investigators determined that 20 patients per group would provide a
power of 95%, with a α level of 5%.
Results will be expressed as means ± Standard Deviation. SPSS 10.0 (Chicago, Illinois, USA)
for the statistical calculation was used. P values < 0.05 were considered statistically
significant. Investigators used the nonparametric t test for normally distributed data, and
the nonparametric Wilcoxon-Mann-Whitney rank test for other data.Investigators used
repeated-measures analysis of variance at four time points (before suctioning, immediately
after suctioning, 3 min after suctioning, and 5 min after suctioning) to analyze changes and
differences in PaO2, heart rate, and mean arterial pressure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05128552 -
Effect of Lung Volume Recruitment Technique After Extubation
|
N/A |