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Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06728709
Acronym
POLUS
Enrollment
280
Registered
2024-12-11
Start date
2024-12-15
Completion date
2026-07-11
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer, Lung Diseases, Obstetric Complication, Ultrasound

Keywords

lung ultrasound, critically ill peripartum, critically ill gynecological cases

Brief summary

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

Detailed description

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

Interventions

DIAGNOSTIC_TESTultrasound detection of any abnormal ultrasonographical findings.

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the Prevalence of different ultrasonographical abnormal lung signaturesFrom date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 dayspresence or absence of us abnormalities as: abnormal sliding, interstitial syndrome, consolidation, cavitation, pleural effusion, or collapse

Secondary

MeasureTime frameDescription
correlation of ultrasonographic finding with mortality or poor outcomefrom the appearance of abnormal ultrasonographic signature to death or disharge from ICU which comes first , assessed up to 20 days from the day of admissionfrequency of occurrence of poor outcomes -mortality or ventilatory support- for every abnormal lung ultrasonographic signature.
timing of appearance of abnormal ultrasonography lung signatureson admission, after every 48 hours during ICU stay till death or dischrage from ICU which comes first, assessed up to 20 days from admissionthe time of detection of the abnormal lung ultrasonographic finding

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORwessam selima, MD

Ain Shams University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026