Clinical trial NCT03828630: Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients
Official title: Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients in an Urban Low-Resource Setting (LUSIP) - an Observational Study in Sierra Leone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Complication
Lung Injury, Acute
Pulmonary Disease
Acute Respiratory Distress Syndrome
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: University of Sierra Leone
name: Doctors with Africa - CUAMM
name: University of Bari
First posted: 2019-02-04
Enrollment: 168
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill parturients admitted to the HDU of the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of parturients with pulmonary complications
timeFrame: From admission to 48 hours later
Secondary outcomes:
measure: Description of lung ultrasound findings
timeFrame: From admission to 48 hours later
measure: Description of diagnoses made with lung ultrasound
timeFrame: From admission to 48 hours later
measure: Relative risk of death in patients with a pulmonary complication
timeFrame: On the day of HDU discharge or death, whichever came first, assessed up to 12 weeks after enrollment
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Princess Christian Maternity Hospital
Study officials:
affiliation: Doctors with Africa - CUAMM
name: Marcella Schiavone, MD, PhD
role: STUDY_CHAIR
affiliation: University of Bari
name: Anna de Nicolo, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sierra Leone
name: Eva Henciles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam
name: Marcus J Schultz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.