Ventilator Associated Pneumonia in Taper Guard Versus Normal Tube in ICU Patients

NCT01501227 | Unknown Phase 4 DMC

• 1 other identifier: MEC 859.8
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

• incidence of ventilator associated pneumonia(VAP)

  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

  72 hours after ventilation initiated to onset of pneumonia

Secondary Outcomes (4)

• Number of days on the ventilator by the time patient is discharged from ICU or hospital or at time of death

  participants will be followed for the duration of ventilation, an expected average of 2 weeks

• The total number of days spent in the intensive care unit by the time of discharge from hospital or death

  participants will be followed for the duration of hospital stay, an expected average of 3 weeks

• The number of days spent in the hospital by the time of discharge or death

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• number of deaths in each arm

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

Taper Guard Endotracheal Tube

ACTIVE COMPARATOR

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

conventional endotracheal tube

SHAM COMPARATOR

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

Interventions

Taper Guard Endotracheal Tube DEVICE

comparison of two different endotracheal tubes

Also known as: Taperguard Evac

Taper Guard Endotracheal Tube

Conventional endotracheal tube OTHER

Sham Comparator

conventional endotracheal tube

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (5)

• 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. doi: 10.1164/rccm.200405-644ST. No abstract available.

  PMID: 15699079 BACKGROUND

• 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.

  PMID: 11778260 RESULT

• 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. doi: 10.1378/chest.121.3.858.

  PMID: 11888973 RESULT

• Lorente L, Lecuona M, Jimenez 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. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.

  PMID: 17872488 RESULT

• 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. doi: 10.1097/CCM.0b013e318218a4d9.

  PMID: 21478738 RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoo-Kuen Chan, FFARCSI

  Department of Anesthesiology, Faculty of Medicine, University of Malaya

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Yoo-Kuen CHAN, FFARCSI

CONTACT

+6012-2937163; chanyk@ummc.edu.my

Vineya RAI, MAnesth; EDIC

CONTACT

+60122157175; vineya74@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 29, 2011
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

MY (1)