Ventilator Associated Pneumonia in Taper Guard Versus Normal Tube in ICU Patients - Full Text View

Purpose

Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients as they may cause the death of the patient or prolong the intensive care stay or complicate the illness in other ways. The risk of infection is dependent on the interplay between bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria load reduction and this includes the use of subglottic suctioning in an attempt to reduce the amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow subglottic suctioning was significantly effective in reducing the incidence of ventilator associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a new tapering design may be even more useful to provide the solution for bacterial load reduction. Conventional tubes which may furrow on themselves to allow the creation of microchannels may aid microaspiration. The taper guard which has facilities for subglottic suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to the problem of ventilator associated pneumonia. This study is to determine the extent of protection this tube has against ventilator associated pneumonia compared with conventional endotracheal tubes

Condition	Intervention	Phase
Ventilator Associated Pneumonia	Device: Taper Guard Endotracheal Tube Other: Conventional endotracheal tube	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of the Incidence of Ventilator Associated Pneumonia in Patients Intubated With the Taper Guard Endotracheal Tube Versus a Normal Endotracheal Tube

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Further study details as provided by University of Malaya:

Primary Outcome Measures:

incidence of ventilator associated pneumonia(VAP) [ Time Frame: 72 hours after ventilation initiated to onset of pneumonia ] [ Designated as safety issue: No ]
the incidence of VAP in patients intubated with the Taper guard tube is compared with the incidence of VAP in patients intubated with the ordinary tube. The criteria for diagnosing VAP is from the American Thoracic Society 2005 guidelines for VAP diagnosis. The assessor for VAP diagnosis is blinded

Secondary Outcome Measures:

Number of days on the ventilator by the time patient is discharged from ICU or hospital or at time of death [ Time Frame: participants will be followed for the duration of ventilation, an expected average of 2 weeks ] [ Designated as safety issue: No ]
The number of days patient is on the ventilator will be monitored between the 2 groups
The total number of days spent in the intensive care unit by the time of discharge from hospital or death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
The length of stay in the intensive care unit will be monitored between the 2 groups
The number of days spent in the hospital by the time of discharge or death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
The length of stay in the hospital will be monitored for the 2 groups
number of deaths in each arm [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
the rate of mortality between the 2 groups will be monitored

Estimated Enrollment:	100
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Taper Guard Endotracheal Tube Patients in the test group will be intubated with the Taper Guard Endotracheal Tube. The incidence of VAP, the length of ventilation, the length of intensive care stay, the length of hospital stay and the mortality rate will be monitored.	Device: Taper Guard Endotracheal Tube comparison of two different endotracheal tubes Other Name: Taperguard Evac
Sham Comparator: conventional endotracheal tube Patients in the placebo comparator group will be intubated with the conventional Endotracheal Tube. The incidence of VAP, the length of ventilation, the length of intensive care stay, the length of hospital stay and the mortality rate will be monitored.	Other: Conventional endotracheal tube Sham Comparator

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All adult patients above 18 years old admitted into the Intensive Care unit and who is to be intubated and likely to receive more than 72 hours of ventilation would be admitted into the trial

Exclusion Criteria:

presence of cavitary lung disease based on chest x-ray findings,
primary lung cancer or another metastatic malignancy to the lungs, or known or suspected viral or fungal etiology,
pneumocystis carinii pneumonia,
legionella OR Mycoplasma pneumonia or active tuberculosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501227

Contacts

Contact: Yoo-Kuen CHAN, FFARCSI	+6012-2937163	chanyk@ummc.edu.my
Contact: Vineya RAI, MAnesth; EDIC	+60122157175	vineya74@yahoo.com

Locations

Malaysia
University of Malaya Medical Centre	Not yet recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Yoo-Kuen Chan, FFARCSI +6012-2937163 chanyk@ummc.edu.my
Contact: Vineya Rai, MBBS;MAnesth;EDIC +60122157175 vineya74@yahoo.com
Principal Investigator: Yoo-Kuen Chan, FFARCSI
Sub-Investigator: Vineya Rai, MAnesth;EDIC
Sub-Investigator: Mohd Shahnaz Hassan, MBBS;MAnesth
Sub-Investigator: Suresh Venogobal, MAnesth, FANZCA
Sub-Investigator: Kang-Kwong Wong, MBBS;MAnesth
Sub-Investigator: Mohd Yasim Yusof, MBBS; MMicrobiology
Sub-Investigator: Foong-Ming Moy, BSc, MScMMedScPH, PhD
Sub-Investigator: Nur Adura Yaakup, MBBS;MRad

Sponsors and Collaborators

University of Malaya

Investigators

Principal Investigator:	Yoo-Kuen Chan, FFARCSI	Department of Anesthesiology, Faculty of Medicine, University of Malaya
Study Director:	Vineya Rai, MAnesth; EDIC	Department of Anesthesiology, Faculty of Medicine, University of Malaya
Study Director:	Mohd Shahnaz Hassan, MBBS;MAnesth	Department of Anesthesiology, Faculty of Medicine, University of Malaya
Study Director:	Suresh Venogobal, MBBS; FANZCA	Department of Anesthesiology, Faculty of Medicine, University of Malaya
Study Director:	Kang-Kwong Wong, MBBS;MAnesth	Department of Anesthesiology, Faculty of Medicine, University of Malaya
Study Director:	Mohd Yasim Yusof, MBBS;MSc Microbiology	Department of Microbiology, Faculty of Medicine, University of Malaya
Study Director:	Foong-Ming Moy, BSc, MSc, MMedSc PH, PhD	Julius Centre University of Malaya, Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya.
Study Director:	Nur Adura Yaakup, MBBS, MRad	Department of Biomedical Imaging, Faculty of Medicine, University of Malaya

More Information

Publications:

Bo H, He L, Qu J. [Influence of the subglottic secretion drainage on the morbidity of ventilator associated pneumonia in mechanically ventilated patients]. Zhonghua Jie He He Hu Xi Za Zhi. 2000 Aug;23(8):472-4. Chinese.

Smulders K, van der Hoeven H, Weers-Pothoff I, Vandenbroucke-Grauls C. A randomized clinical trial of intermittent subglottic secretion drainage in patients receiving mechanical ventilation. Chest. 2002 Mar;121(3):858-62.

Lorente L, Lecuona M, Jiménez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. Epub 2007 Sep 13.

Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. Review.

American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. No abstract available.

Responsible Party:	Chan Yoo Kuen, Professor, University of Malaya
ClinicalTrials.gov Identifier:	NCT01501227 History of Changes
Other Study ID Numbers:	MEC 859.8
Study First Received:	December 12, 2011
Last Updated:	December 28, 2011
Health Authority:	Malaysia: Ministry of Health

Keywords provided by University of Malaya:

ventilator associated pneumonia

Additional relevant MeSH terms:

Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on May 22, 2013