Visual Sputum Suctioning System Tests in Mechanically Ventilated Patients

NCT02116491 | Unknown Phase 1 DMC

• 1 other identifier: JWu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ineffective Airway Clearance; Respiratory Tract Hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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.

• Rate of hemorrhage

  Patients will be followed until 2 hour after suction.

Secondary Outcomes (1)

• Weight gain of the suction catheter

  Until finished suctioning (An expected average of 10 min)

Study Arms (2)

Closed suction system

NO INTERVENTION

All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Cloesd suction system was performed which the patient remained connected to the ventilator. The catheter was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating.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.

Visual Sputum Suctioning System

EXPERIMENTAL

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.

Device: Visual Sputum Suctioning System

Interventions

Visual Sputum Suctioning System DEVICE

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.

Also known as: VSSS

Visual Sputum Suctioning System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to RICU
• years old or more
• Ventilated more than 24 hours mechanical ventilation
• Patients with stability (MAP\>70 mmHg, HR\<130 b/min)
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Gerontology, First Affiliated Hospital of Chongqing Medical University,

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (6)

• 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. doi: 10.1016/s0004-9514(05)70050-7.

  PMID: 15748122 BACKGROUND

• 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.

  PMID: 20332576 BACKGROUND

• Barnes CA, Kirchhoff KT. Minimizing hypoxemia due to endotracheal suctioning: a review of the literature. Heart Lung. 1986 Mar;15(2):164-76. No abstract available.

  PMID: 3512492 BACKGROUND

• 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. doi: 10.1164/ajrccm/144.2.395.

  PMID: 1859066 BACKGROUND

• 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. doi: 10.1164/rccm.200203-195OC. Epub 2003 Feb 13.

  PMID: 12615633 BACKGROUND

• Almgren B, Wickerts CJ, Heinonen E, Hogman M. Side effects of endotracheal suction in pressure- and volume-controlled ventilation. Chest. 2004 Mar;125(3):1077-80. doi: 10.1378/chest.125.3.1077.

  PMID: 15006972 BACKGROUND

Study Officials

• Jinxing Wu, PhD, Pro

  Department of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, China

  STUDY CHAIR

Central Study Contacts

Xun Liu, MD

CONTACT

(86) -13983239458; liuxunhi@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: April 12, 2014
• First Posted: April 17, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

CN (1)