A New Way of Looking at Your Lungs

NCT01949402 | Completed

• 1 other identifier: TUS-EVLW1
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing interest in how thoracic (chest) ultrasound might enhance the management of patients with respiratory failure and breathlessness, particularly in the emergency admissions or intensive care setting. Thoracic ultrasound is already used in a number of clinical settings. It is recognised that a number of lung abnormalities can be identified using thoracic ultrasound, such as consolidation (in pneumonia) or peripheral soft tissue lesions (in lung cancer). Furthermore, thoracic ultrasound offers clinicians a non-invasive diagnostic tool that provides immediate feedback and results. Patients with breathlessness and respiratory failure represent a significant proportion of emergency admissions to hospital and commonly require urgent treatment with limited information available to guide the clinician. The range of diseases that present with breathing difficulties is broad (e.g. pneumonia, heart failure, pulmonary embolus) and difficult to differentiate in patients who often have multiple medical problems. This leads to non-specific treatment in the face of diagnostic uncertainty with the associated risks of treatment complications, increased morbidity and mortality, and distress for patients and relatives. It is in the assessment of these patients with acute respiratory failure where thoracic ultrasound might be of greatest benefit and which this research is designed to address. This is a single centre study (Churchill Hospital, Oxford) recruiting 125 participants over an eight month period. The study will test the reliability of a thoracic ultrasound protocol at identifying lung abnormalities in a stable outpatient population with respiratory disease (chronic obstructive pulmonary disease; interstitial lung disease; patients on haemodialysis to replicate acute pulmonary oedema / heart failure). It is hoped the results of this study will inform further research in acutely unwell patients with respiratory failure and breathlessness to see whether thoracic ultrasound can improve diagnostic and therapeutic decisions.

Conditions

Respiratory Failure; Acute Dyspnoea

Outcome Measures

Primary Outcomes (1)

• The total lung ultrasound B-line score.

  The total lung ultrasound B-line score (representing the presence of extravascular lung water) and changes in overall fluid status during haemodialysis.

  At enrollment (1 single visit only)

Secondary Outcomes (4)

• Lung ultrasound identification of B-lines and differentiation between extravascular lung water

  At enrollment (1 single visit only)

• The lung ultrasound B-line score at differing anatomical locations around the thoracic cage

  at enrollment (1 single visit only)

• The total lung ultrasound B-line score

  At enrollment (1 single visit only)

• Patient satisfaction with the thoracic ultrasound protocol

  At enrollment (1 single visit only)

Study Arms (4)

Haemodialysis

Patients with end-stage renal failure (ESRF) requiring long-term regular haemodialysis.

Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests

Chronic Obstructive Pulmonary Disease

Patients with a confirmed diagnosis of COPD based on clinical history, obstructive spirometry (FEV1/VC ratio \<70%) and radiology (e.g. hyperexpansion on plain chest radiograph; evidence of small airways disease or emphysema on cross-sectional imaging).

Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests

Interstitial Lung Disease

Patients with a confirmed diagnosis of ILD based on clinical history and radiology (evidence of ILD on cross-sectional imaging).

Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests

Control

Age-matched healthy volunteers with no history of cardiac, respiratory or renal disease.

Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests

Interventions

Computed Tomography OTHER

The CT scan will be performed on a 16 slice GE Discovery 670 SPECT CT scanner. A slice thickness of 0.625mm will be used. Images are acquired during an inspiratory breath hold of up to 20 seconds to minimise movement artefact. The patient will be lying supine and the scan will be a non-contrast study. Using a low dose CT chest protocol (1.7 mSv) will minimise the exposure to ionising radiation of study participants. Participants in the haemodialysis arm of the study will have a CT done before and after haemodialysis. Participants in all other arms will have a single CT scan done during their study "visit".

Chronic Obstructive Pulmonary Disease; Control; Haemodialysis; Interstitial Lung Disease

Thoracic ultrasound OTHER

The ultrasound will be performed by a single operator. The patient's position will ideally be with the patient sitting up at 45°. Ultrasound images and clips will be recorded at 10 points over each hemithorax - the 2nd, 4th and 6th intercostal spaces (ICS) in the mid-clavicular line; the 2nd, 4th and 6th ICS in the mid-axillary line; and the 2nd, 5th, 7th and 9th ICS posteriorly. Ultrasound estimation of the height of the right internal jugular vein will be undertaken. Central venous pressure will be calculated by adding 5cm. Inferior vena cava diameter will also be measured at end-inspiration and expiration. The time taken to perform each ultrasound will be recorded. Control, COPD and ILD groups will be scanned on a single occasion. Haemodialysis group will have 4 scans.

Chronic Obstructive Pulmonary Disease; Control; Haemodialysis; Interstitial Lung Disease

Spirometry OTHER

All participants in the study will undergo basic spirometry as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study.

Chronic Obstructive Pulmonary Disease; Control; Haemodialysis; Interstitial Lung Disease

Blood tests OTHER

All participants in the study will undergo blood tests as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study.

Chronic Obstructive Pulmonary Disease; Control; Haemodialysis; Interstitial Lung Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be screened from normal clinical care in the outpatient haemodialysis unit and specialist respiratory clinics (COPD and ILD) at the Churchill Hospital, Oxford. Age-matched volunteers will also be sought for the control arm of the study.

You may qualify if:

• Haemodialysis (n=50) - patients with end-stage renal failure (ESRF) requiring long-term regular haemodialysis.
• Chronic Obstructive Pulmonary Disease (COPD) (n=25) - patients with a confirmed diagnosis of COPD based on clinical history, obstructive spirometry (FEV1/VC ratio \<70%) and radiology (e.g. hyperexpansion on plain chest radiograph; evidence of small airways disease or emphysema on cross-sectional imaging).
• Interstitial Lung Disease (ILD) (n=25) - patients with a confirmed diagnosis of ILD based on clinical history and radiology (evidence of ILD on cross-sectional imaging).
• Control (n=25) - age-matched healthy volunteers with no history of cardiac, respiratory or renal disease.

You may not qualify if:

• Age \< 18 years
• Inability to provide informed consent to participate in the study
• Pregnant or breastfeeding
• Known diagnosis of heart failure or chronic renal failure in participants recruited to the COPD or ILD arms of the study.
• Known diagnosis of COPD or ILD in participants recruited to the haemodialysis arm of the study.
• Known history of cardiac, respiratory or renal disease in participants recruited to the control arm of the study.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Respiratory Trials Unit

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Najib Rahman, DPhil

  University of Oxford

  STUDY CHAIR

• John Corcoran, BM BCh

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Fergus Gleeson, Prof

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: February 1, 2014
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

GB (1)