Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients

Acute Respiratory Distress Syndrome Clinical Trial

— LUSIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828630
• Other study ID #: LUSIP
• Status: Completed
• Start date: July 8, 2018
• Est. completion date: March 28, 2019

Study information

• Verified date: April 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Critical Illness
• Lung Diseases
• Lung Injury
• Lung Injury, Acute
• Obstetric Complication
• Pulmonary Disease
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Sierra Leone	Princess Christian Maternity Hospital	Freetown

Sponsors (5)

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

Country where clinical trial is conducted

Sierra Leone, 

References & Publications (2)

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

Outcome

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