Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients

NCT03828630 | Completed

• 1 other identifier: LUSIP
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Description of lung ultrasound findings

  From admission to 48 hours later

• Description of diagnoses made with lung ultrasound

  From admission to 48 hours later

• Relative risk of death in patients with a pulmonary complication

  On the day of HDU discharge or death, whichever came first, assessed up to 12 weeks after enrollment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Admitted to the HDU of the PCMH during the study period
• Verbal informed consent of the patient or his/her formal representative

You may not qualify if:

• Lung ultrasound not feasible, e.g., due to electricity breakdown, or absence of the trained sonographer.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• University of Sierra Leone: collaborator
• Doctors with Africa - CUAMM: collaborator
• University of Bari: collaborator

Study Sites (1)

Princess Christian Maternity Hospital

Freetown, Sierra Leone

Location

Related 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.

  PMID: 30540757 BACKGROUND

• 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.

  PMID: 29368056 BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury; Lung Diseases; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Marcella Schiavone, MD, PhD

  Doctors with Africa - CUAMM

  STUDY CHAIR

• Anna de Nicolo, MD, PhD

  University of Bari

  STUDY CHAIR

• Eva Henciles, MD

  University of Sierra Leone

  PRINCIPAL INVESTIGATOR

• Marcus J Schultz, MD, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 4, 2019
• Study Start: July 8, 2018
• Primary Completion: February 27, 2019
• Study Completion: March 28, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

SI (1)