Bedside Measurement of Ventilation With or Without a One-way Valve During Lung Lavage

NCT01143961 | Completed

• 1 other identifier: 09/MRE09/54
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Surveillance of the lungs for bacteria is routinely undertaken in artificially ventilated patients as these individuals are at high risk of developing pneumonia. Knowledge of the types of bacteria present allows the rapid treatment with the correct antibiotics if a pneumonia develops. Surveillance is undertaken using a technique called non-directed bronchoalveolar lavage (NBL), which can be performed by the bedside nurse. This involves suctioning some of the lung secretions into a sample pot and sending it to the microbiology laboratory to identify any bacteria present. When this procedure is performed there is some collapse of the lung due to escaping gas. The purpose of this study is:

1. 1.To use a non-invasive imaging technique known as electrical impedance tomography (EIT) to measure the amount of lung collapse during an NBL. Half of the patients in the study will have a one-way adapter valve connected to the breathing circuit. This adapter is designed to make the insertion of a suction catheter easier and prevent the loss of gas.
2. 2.Look at which region of the lung the sample is being collected from as the suction tube used to take the samples may pass into either the left or right lung.

Conditions

Intensive Care

Keywords

Positive pressure ventilation; Electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• Measure changes in lung ventilation using EIT during the performance of an NBL with and without a one-way adapter valve attached to the catheter mount.

  Up to 4 hours

Secondary Outcomes (1)

• Locate the placement of catheter tips during the performance of NBLs, using electrical impedance tomography

  Up to 4 hours

Study Arms (2)

NBL with one-way valve

EXPERIMENTAL

NBL performed with one-way valve in ventilator circuit during procedure

Device: CSC100 - Verso airway access adapter CareFusion

Standard NBL

NO INTERVENTION

Performance of standard NBL with recording of changes in regional ventilation by electrical impedance tomography

Interventions

CSC100 - Verso airway access adapter CareFusion DEVICE

Following randomisation patients will have a one-way valve inserted into the ventilator circuit (CSC100 - Verso airway access adapter CareFusion) prior to a non-directed bronchoalveolar lavage (NBL) being performed. Changes in regional ventilation will be recorded by electrical impedance tomography during the NBL. Recordings of ventilation will take place for upto four hours. One-way valve will stay in place until ventilator circuit is changed.

Also known as: One-way adapter valve

NBL with one-way valve

Eligibility Criteria

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

You may qualify if:

• Patients aged \>18 years
• Patients in whom an NBL is indicated as part of standard treatment
• Patient on mechanical ventilation with PEEP

You may not qualify if:

• NBL contraindicated
• Age \<18 years
• Patient not on mechanical ventilation with PEEP

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Adult Critical Care, University Hospital of Wales

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

Location

Study Officials

• Matt P Wise, DPhil

  University Hospital of Wales Cardiff & Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 31, 2023

Record last verified: 2010-02

Locations

GB (1)