Test of a Novel Visual Sputum Suctioning System in Mechanically Ventilated Patients
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from Baseline in hemodynamic and respiratory data at 5 min
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients admitted to RICU
- •18 years old or more
- •Ventilated more than 24 hours mechanical ventilation
- •Patients with stability (MAP>70 mmHg, HR<130 b/min)
- •Signed informed consent
Exclusion Criteria
- •Current or past participation in another intervention trial conflicting with the present study patients with stupor and coma
- •Any clinical events or practitioner interventions within 15 min prior to study enrollment (eg, a change in ventilator settings, hemodynamic instability [DBP >100 mmHg; ↑or 20mmHg in PaO2; ↑20 b/min in HR]; sever hypoxemia [SpO2<85%, PaO2<50mmHg])
- •Had heart or lung or heart transplantation.
- •Had massive hemoptysis.
- •Pregnant women
Outcomes
Primary Outcomes
Change from Baseline in hemodynamic and respiratory data at 5 min
Time Frame: Patients will be followed until 2 hour after suction.
The hemodynamic and respiratory data including heart rate, arterial partial pressure of oxygen and mean arterial pressure will be recorded before (baseline), immediately after, 3 min after, and 5 min after suctioning.
Rate of hemorrhage
Time Frame: Patients will be followed until 2 hour after suction.
Secondary Outcomes
- Weight gain of the suction catheter(Until finished suctioning (An expected average of 10 min))
Investigators
Jinxing Wu
PhD, Professor
First Affiliated Hospital of Chongqing Medical University