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Visual Sputum Suctioning System Tests in Mechanically Ventilated Patients

NCT02116491 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-04-17

No results posted yet for this study

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.

Conditions

  • Ineffective Airway Clearance
  • Respiratory Tract Hemorrhage

Interventions

DEVICE

Visual Sputum Suctioning System

All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Closed suction system was performed which the patient remained connected to the ventilator. The double-lumen catheter of the Visual Sputum Suctioning System integrated with a 0.9-mm micro-imaging fiber was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures.

Sponsors & Collaborators

  • First Affiliated Hospital of Chongqing Medical University

    lead OTHER

Principal Investigators

  • Jinxing Wu, PhD, Pro · Department of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116491 on ClinicalTrials.gov