Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients (LUSIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Pulmonary Disease; Obstetric Complication; Lung Injury, Acute

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.

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• Sierra Leone
  • Freetown, Sierra Leone
    • Princess Christian Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: University of Sierra Leone; University of Bari; Doctors with Africa - CUAMM; Mahidol Oxford Tropical Medicine Research Unit
• Investigators: Study Chair: Marcella Schiavone, MD, PhD, Doctors with Africa - CUAMM; Study Chair: Anna de Nicolo, MD, PhD, University of Bari; Principal Investigator: Eva Henciles, MD, University of Sierra Leone; Principal Investigator: Marcus J Schultz, MD, PhD, University of Amsterdam

Publications and helpful links

General Publications

• 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. Erratum In: Intensive Care Med. 2018 Feb 20;:

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2018
• Primary Completion (Actual): February 27, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: LUSIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No