Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr D Thickett


Contact details

Respiratory Medicine
Queen Elizabeth Hospital
B15 2TH
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Does routine quantitative culture of BronchoAlveolar Lavage (BAL) improve delivery of care and functionally important outcomes in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS)?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Respiratory: Acute Respiratory Distress Syndrome (ARDS) + Acute Lung Injury (ALI)


1. Identify patients suitable for inclusion into study
2. Seek consultant assent (not one of the investigators) to enter patient into study
3. Randomise to quantitative or non-quantitative culture
4. Day one to two BronchoAlveolar Lavage (BAL) and peripheral blood sample (50 ml arterial blood, 5 ml venous blood)
5. Day four to six BAL and blood (l0 ml)
6. Day seven to nine BAL and blood (l0 ml)
7. Day 12 to 14 BAL and blood (l0 ml)
8. Weekly BAL and blood sampling thereafter. Sampling protocol based on evidence which shows that approximately 80% of episodes of Ventilator-Associated Pneumonia (VAP) occur in the first two weeks of invasive ventilation (Markowicz P, Wolff M, Djedaini K, et al: Multicenter prospective study of ventilator-associated pneumonia during ARDS. Am J Respir Crit Care Med 2000, 161:1942-1948).
9. Retrospective consent to take part in study, and to use retained specimens for research. Several models of consent have been applied to patients receiving intensive care. All, however, contain difficult issues regarding the competency of these patients to give informed consent at the proposed point of enrolment into the study. Following discussion with Dr C Counsell (R&D Support), we propose that Bronchoscopy/BAL is in the best interests of patients as it provides the best method of obtaining samples for microbiological analysis from the lungs of ventilated patients. Furthermore, BAL would form part of the routine investigative work-up for patients suspected of having VAP. In addition, BAL is recommended in severe ALI/ARDS to exclude sepsis prior to the commencement of systemic corticosteroids (Meduri GU, Chinn AJ, Leeper KV et al: Corticosteroid rescue treatment of progressive fibroproliferation in late ARDS: patterns of response and predictors of outcome. Chest 1994, 105:1516-1527). Therefore, informed consent for inclusion into the study, storage of patient data and storage of biological specimens for subsequent analysis will be sought retrospectively from patients after recruitment. Patients will also be asked to provide consent to attend a three month post-Intensive Care Unit (ICU) follow up clinic for assessment of functional outcomes and health status
10. Survivors: Follow-up research clinic at three months at Wellcome Clinical Research Facility (CRF)
a. Health questionnaires
b. Full Pulmonary Function Tests
c. Shuttle walk
d. Bronchoscopy and BAL
11. Further follow-up at 12 months for quantitative density mask analysis of High Resolution Computed Tomography (CT) Thorax if suspected residual pulmonary fibrosis or bronchiectasis from 9., above. This would be my standard clinical management if I saw these patients in Out-Patients Department (OPD) at follow up

Intervention type



Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged over 16 years
2. Patient receiving mechanical ventilation
3. Existence of, or risk factors for, ALI/ARDS

Participant type


Age group



Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Pregnancy
2. Patient already enrolled in another interventional study
3. Little chance of survival, defined by Simplified Acute Physiologic Score II (SAPS II), over 65 points corresponds to predicted mortality in excess of 77%
4. Contraindication to bronchoscopy at enrolment

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Medicine
B15 2TH
United Kingdom

Sponsor information


Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 safety and tolerability results in

Publication citations

  1. Safety and tolerability results

    Perkins GD, Chatterjee S, Giles S, McAuley DF, Quinton S, Thickett DR, Gao F, Safety and tolerability of nonbronchoscopic lavage in ARDS., Chest, 2005, 127, 4, 1358-1363, doi: 10.1378/chest.127.4.1358.

Additional files

Editorial Notes