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Completed

NCT Number: NCT06728709

Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients

Pulmonary dysfunction aggravates the illness of critically ill obstetrics and gynecological patients. Early identification with bedside technique and prompt management may improve the outcome of critical care in this vulnerable population

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Ain shams university

Cairo, Cairo Governorate, 11528, Egypt

About this study

Hormonal changes in a woman's menstrual cycle and changes during pregnancy affect the respiratory system. These changes especially during pregnancy and peripartum complicate the critical care management of the female patients. In addition to the effect of different pregnancy-related as sepsis, and preeclampsia which directly or indirectly predispose to pulmonary complications.

The presence of difficulty in the transfer of critically ill patients mandates point of care modality. Avoidance of fetal exposure to hazardous radiation demands safe technology. Ultrasound arises as a screening method that can be performed rapidly and enables healthcare providers to make timely decisions with no radiation exposure. Thus it facilitates the management of critically ill obstetric and gynecological patients.

When compared to other imaging techniques; X-ray imaging is preferably restricted in parturient because of the ionizing risk on the fetus, and CT is not feasible in critically ill if there is a risk of transfer. Thus ultrasound emerged as a bedside imaging technique.

Yet, the prevalence of the specific ultrasound signatures in that population is not clearly defined and its relation to poor outcome was not tested, This trial is the first trial to determine frequency, timing concerning admission, type of pulmonary abnormalities detectable by LUS, and their associations with poor outcome in patients whether obstetrics or gynecology admitted to the ICU specialized in women's intensive care

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient admitted to the obstetrics and gynecology intensive care unit

Exclusion criteria

  • Patient's refusal
  • inability to do a lung ultrasound examination during the first 24 hours of admission

Treatment and study plan

ultrasound detection of any abnormal ultrasonographical findings.

Diagnostic Test

ultrasound assessment within 24 hours. Then reassessment every 48 hours or when the patient develops respiratory distress.

While the patient is in a supine or semi-recumbent position, and the probe is in a short axis. The 8-region technique will be used. The areas are four on each side of the chest. The examiner will assess 8 regions -Anterior chest wall ( ACW), Anterior axillary line (AAXL), costo-phrenic angle (COSTO), Postero-lateral alveolar &/ or pleural syndrome (PLAPS) right and left . Each region will be scored using the LUS aeration score. as follows: "0," A-pattern with 0-2 B-lines; "1," more than 2 separated B-lines; "2," multiple coalescent B-lines; or "3," lung consolidation, . A global LUS score will be calculated at each time point and range from 0 to 24.

posterior region will be assessed if needed and if feasible. The venous status will be assessed through a subcostal view for inferior vena cava diameter.

Primary outcomes

  1. the Prevalence of different ultrasonographical abnormal lung signatures

    Time frame: From date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 days

    presence or absence of us abnormalities as: abnormal sliding, interstitial syndrome, consolidation, cavitation, pleural effusion, or collapse

Secondary outcomes

  1. correlation of ultrasonographic finding with mortality or poor outcome

    Time frame: from the appearance of abnormal ultrasonographic signature to death or disharge from ICU which comes first , assessed up to 20 days from the day of admission

    frequency of occurrence of poor outcomes -mortality or ventilatory support- for every abnormal lung ultrasonographic signature.

  2. timing of appearance of abnormal ultrasonography lung signatures

    Time frame: on admission, after every 48 hours during ICU stay till death or dischrage from ICU which comes first, assessed up to 20 days from admission

    the time of detection of the abnormal lung ultrasonographic finding

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Perioperative Lung Ultrasound Phenotypes and Clinical Outcomes in Critically Ill Obstetrics and Gynaecologic Patients (POLUS): A Prospective Cohort Study

Acronym: POLUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Jul 14, 2026

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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