Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients

Study Overview
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Brief Summary
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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.

Detailed Description
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Rationale: The three big 'killers' in parturients, peripartum hemorrhage, sepsis and pre-eclampsia all predispose to pulmonary complications. These complications affect management before, during and after the primary obstetric problem has been solved. A timely diagnosis and thorough follow-up of pulmonary complications may benefit parturients. Lung ultrasound (LUS) is a point-of-care imaging bedside tool increasingly used in the critical care setting that may prove useful in parturients. 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.

Official Title
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Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients in an Urban Low-Resource Setting (LUSIP) - an Observational Study in Sierra Leone

Conditions
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Pulmonary Disease, Obstetric Complication, Lung Injury, Acute, Acute Respiratory Distress Syndrome

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |