Visual Sputum Suctioning System Tests in Mechanically Ventilated Patients

Ineffective Airway Clearance Clinical Trial

Official title:

Test of a Novel Visual Sputum Suctioning System in Mechanically Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02116491
• Other study ID #: JWu
• Status: Recruiting
• Phase: Phase 1
• First received: April 12, 2014
• Last updated: April 15, 2014
• Start date: March 2014
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Xun Liu, MD
• Phone: (86) -13983239458
• Email: liuxunhi[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ineffective Airway Clearance
• Respiratory Tract Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
China	Department of Gerontology, First Affiliated Hospital of Chongqing Medical University,	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Almgren B, Wickerts CJ, Heinonen E, Högman M. Side effects of endotracheal suction in pressure- and volume-controlled ventilation. Chest. 2004 Mar;125(3):1077-80. — View Citation

Barnes CA, Kirchhoff KT. Minimizing hypoxemia due to endotracheal suctioning: a review of the literature. Heart Lung. 1986 Mar;15(2):164-76. Review. — View Citation

Brochard L, Mion G, Isabey D, Bertrand C, Messadi AA, Mancebo J, Boussignac G, Vasile N, Lemaire F, Harf A. Constant-flow insufflation prevents arterial oxygen desaturation during endotracheal suctioning. Am Rev Respir Dis. 1991 Aug;144(2):395-400. — View Citation

Choi JS, Jones AY. Effects of manual hyperinflation and suctioning in respiratory mechanics in mechanically ventilated patients with ventilator-associated pneumonia. Aust J Physiother. 2005;51(1):25-30. — View Citation

Maggiore SM, Lellouche F, Pigeot J, Taille S, Deye N, Durrmeyer X, Richard JC, Mancebo J, Lemaire F, Brochard L. Prevention of endotracheal suctioning-induced alveolar derecruitment in acute lung injury. Am J Respir Crit Care Med. 2003 May 1;167(9):1215-24. Epub 2003 Feb 13. — View Citation

Yorioka K, Oie S, Kamiya A. Microbial contamination of suction tubes attached to suction instruments and preventive methods. Jpn J Infect Dis. 2010 Mar;63(2):124-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in hemodynamic and respiratory data at 5 min	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.	Patients will be followed until 2 hour after suction.	Yes
Primary	Rate of hemorrhage		Patients will be followed until 2 hour after suction.	Yes
Secondary	Weight gain of the suction catheter	Weight gain of the suction catheter due to secretions will be measured by mean of a high precision laboratory scale.	Until finished suctioning (An expected average of 10 min)	No