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Completed

NCT Number: NCT03828630

Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients

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.

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Key information

Conditions

Obstetric Complication Acute Lung Injury Acute Respiratory Distress Syndrome Lung Diseases Lung Injury Lung Injury, Acute Pulmonary Disease Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Princess Christian Maternity Hospital

Freetown, Sierra Leone

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of parturients with pulmonary complications

    Time frame: From admission to 48 hours later

    proportion of parturients with pulmonary complications detected by LUS during stay in the HDU.

Secondary outcomes

  1. Description of lung ultrasound findings

    Time frame: From admission to 48 hours later

    Precise description of ultrasound findings (proportion of patients with a normal lung, interstitial syndrome, lung consolidation, pleural effusion)

  2. Description of diagnoses made with lung ultrasound

    Time frame: From admission to 48 hours later

    Proportion of patients with a diagnosis of pneumonia, acute respiratory distress syndrome, fluid overload, no pulmonary complication.

  3. Relative risk of death in patients with a pulmonary complication

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

    Risk of death in the group with pulmonary complication divided by the risk of death in parturients without a pulmonary complication

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Doctors with Africa - CUAMM
  • Mahidol Oxford Tropical Medicine Research Unit
  • University of Bari
  • University of Sierra Leone

Registry information

Official study title

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

Acronym: LUSIP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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