Acute Respiratory Distress Syndrome Clinical Trial
— LUSIPOfficial title:
Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients in an Urban Low-Resource Setting (LUSIP) - an Observational Study in Sierra Leone
NCT number | NCT03828630 |
Other study ID # | LUSIP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 8, 2018 |
Est. completion date | March 28, 2019 |
Verified date | April 2019 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims at describing the frequency, timing and type of pulmonary complications detected with lung ultrasound in critically-ill parturients in admitted to a high-dependency unit in Freetown, Sierra Leone.
Status | Completed |
Enrollment | 168 |
Est. completion date | March 28, 2019 |
Est. primary completion date | February 27, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Admitted to the HDU of the PCMH during the study period - Verbal informed consent of the patient or his/her formal representative Exclusion Criteria: - Lung ultrasound not feasible, e.g., due to electricity breakdown, or absence of the trained sonographer. |
Country | Name | City | State |
---|---|---|---|
Sierra Leone | Princess Christian Maternity Hospital | Freetown |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Doctors with Africa - CUAMM, Mahidol Oxford Tropical Medicine Research Unit, University of Bari, University of Sierra Leone |
Sierra Leone,
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. — View Citation
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. Erratum in: Intensive Care Med. 2018 Feb 20;:. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of parturients with pulmonary complications | proportion of parturients with pulmonary complications detected by LUS during stay in the HDU. | From admission to 48 hours later | |
Secondary | Description of lung ultrasound findings | Precise description of ultrasound findings (proportion of patients with a normal lung, interstitial syndrome, lung consolidation, pleural effusion) | From admission to 48 hours later | |
Secondary | Description of diagnoses made with lung ultrasound | Proportion of patients with a diagnosis of pneumonia, acute respiratory distress syndrome, fluid overload, no pulmonary complication. | From admission to 48 hours later | |
Secondary | Relative risk of death in patients with a pulmonary complication | Risk of death in the group with pulmonary complication divided by the risk of death in parturients without a pulmonary complication | On the day of HDU discharge or death, whichever came first, assessed up to 12 weeks after enrollment |
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