Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients
NCT ID: NCT03828630
Last Updated: 2019-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2018-07-08
2019-03-28
Brief Summary
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Detailed Description
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Objective: To describe frequency, timing and type of pulmonary complications detected with LUS in critically ill parturients in a high-dependency unit (HDU), and to determine the association with outcome.
Hypotheses: Pulmonary complications detected by LUS are frequent in parturients admitted to a HDU in a resource-limited setting, and are associated with hospital mortality.
Study design: A prospective observational study. Study population: Critically ill parturients admitted to the HDU of the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
Sample size: No formal sample size calculation is performed. Based on current rates of admissions to the HDU of the PCMH the investigators expect to perform LUS in at least 125 patients.
Methods: A trained physician performs all 12-region LUS investigations. LUS is performed at admission, after 24 and 48 hours, and when a patient's respiratory condition deteriorates. LUS findings are reported using a standardized semi-quantitative visual LUS scoring method.
Main study parameters/primary endpoints: The proportion of critically ill parturients admitted to the HDU of the PCMH with pulmonary complications detected by LUS, including interstitial syndrome, pulmonary consolidation, and pleural effusion.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Verbal informed consent of the patient or his/her formal representative
Exclusion Criteria
FEMALE
No
Sponsors
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Mahidol Oxford Tropical Medicine Research Unit
OTHER
University of Sierra Leone
OTHER
Doctors with Africa - CUAMM
OTHER
University of Bari
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Marcus J. Schultz
Professor
Principal Investigators
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Marcella Schiavone, MD, PhD
Role: STUDY_CHAIR
Doctors with Africa - CUAMM
Anna de Nicolo, MD, PhD
Role: STUDY_CHAIR
University of Bari
Eva Henciles, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sierra Leone
Marcus J Schultz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Amsterdam
Locations
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Princess Christian Maternity Hospital
Freetown, , Sierra Leone
Countries
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References
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Leopold SJ, Ghose A, Plewes KA, Mazumder S, Pisani L, Kingston HWF, Paul S, Barua A, Sattar MA, Huson MAM, Walden AP, Henwood PC, Riviello ED, Schultz MJ, Day NPJ, Kumar Dutta A, White NJ, Dondorp AM. Point-of-care lung ultrasound for the detection of pulmonary manifestations of malaria and sepsis: An observational study. PLoS One. 2018 Dec 12;13(12):e0204832. doi: 10.1371/journal.pone.0204832. eCollection 2018.
Vercesi V, Pisani L, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MMA, Henwood PC, Walden A, Smit M, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. External confirmation and exploration of the Kigali modification for diagnosing moderate or severe ARDS. Intensive Care Med. 2018 Apr;44(4):523-524. doi: 10.1007/s00134-018-5048-5. Epub 2018 Jan 24. No abstract available.
Other Identifiers
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LUSIP
Identifier Type: -
Identifier Source: org_study_id
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