Reduced Ventilator-Free Days and Bacterial Colonization of Sub-Glottic Secretions

NCT02311296 | Withdrawn

• 1 other identifier: HI-LO Study
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source of infection among patients receiving mechanical ventilation. Patients on mechanical ventilation accumulate secretion leading to aspiration of infected secretions. Using new generation endotracheal tube (Hi-Lo tube) can reduce the incidence of VAP.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• To determine time course and incidence of bacterial colonization of subglottic secretions

  first 72 hours of receiving mechanical ventilation

Secondary Outcomes (1)

• Patients with bacterial colony counts greater than Log(10)4 after 72 hours

  after 72 hours of ventilation have reduction of ventilator free days at Day 14

Other Outcomes (1)

• Secretion of HSP-70 into subglottic secretions

  through Day 14

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients on mechanical ventilation

You may qualify if:

• Age \> 18 years of age
• Patients requiring mechanical ventilation for altered mental status, drug overdose or any condition that airway protection from aspiration is clinically warranted
• Patients requiring mechanical ventilation following Cardiothoracic bypass or valve replacement surgery
• Patients requiring mechanical ventilation for stroke, intra-cranial bleed, sub-dural hematoma, meningitis or closed head injury
• Patients requiring mechanical ventilation for following of abdominal surgery in which there were no discernable infiltrates on chest X-ray
• Patients requiring mechanical ventilation for primary lung disease (COPD, emphysema etc.) if no discernable infiltrates on chest X-ray.

You may not qualify if:

• \) Patients receiving mechanical ventilation for greater than 6 hrs at the time of enrollment.
• \) Patients requiring mechanical ventilation for ARDS, pneumonia or traumatic lung injury.
• \) Patients receiving more than one dose of any antibiotic.
• \) Patients undergoing surgical resection for lung cancer or any other surgery directly involving lung parenchyma

Sponsors & Collaborators

• University of Tennessee, Chattanooga: lead

Study Sites (1)

Erlanger Hospital

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John Gunter, MD

  University of Tennessee, Chattanooga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: December 8, 2014
• Study Start: November 2, 2020
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

US (1)