A New Way of Looking at Your Lungs

NCT01949402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2017-05-16

No results posted yet for this study

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

Interventions

OTHER

Spirometry

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.

OTHER

Computed Tomography

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".

OTHER

Thoracic ultrasound

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.

OTHER

Blood tests

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.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Najib Rahman, DPhil · University of Oxford

  • John Corcoran, BM BCh · University of Oxford

  • Fergus Gleeson, Prof · Oxford University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949402 on ClinicalTrials.gov