Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients (POLUS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Gynecologic Cancer; Ultrasound; Obstetric Complication
• Intervention / Treatment: Diagnostic test: ultrasound detection of any abnormal ultrasonographical findings.

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

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: wessam selima, MD; Phone Number: 01001958858; Email: w.z.selima@gmail.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11528
      • Recruiting
      • Ain shams university
      • Contact: Anesthesia department; Phone Number: 010009499962; Email: anesth_office@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

critically ill women admitted in the ICU for any medical, obstetric, or surgical causes.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obstetrics critically ill; critically ill obstetrics patients admitted yo ICU for any cause during pregnancy or postpartum.	Diagnostic test: ultrasound 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.
gynecological critically ill patients; gynecological cases admitted to ICU for any cause of medical or postoperative care	Diagnostic test: ultrasound 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Prevalence of different ultrasonographical abnormal lung signatures	presence or absence of us abnormalities as: abnormal sliding, interstitial syndrome, consolidation, cavitation, pleural effusion, or collapse	From date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation of ultrasonographic finding with mortality or poor outcome	frequency of occurrence of poor outcomes -mortality or ventilatory support- for every abnormal lung ultrasonographic signature.	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
timing of appearance of abnormal ultrasonography lung signatures	the time of detection of the abnormal lung ultrasonographic finding	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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: wessam selima, MD, Ain shams university

Publications and helpful links

General Publications

• Rocca E, Zanza C, Longhitano Y, Piccolella F, Romenskaya T, Racca F, Savioli G, Saviano A, Piccioni A, Mongodi S. Lung Ultrasound in Critical Care and Emergency Medicine: Clinical Review. Adv Respir Med. 2023 May 17;91(3):203-223. doi: 10.3390/arm91030017.
• Pisani L, De Nicolo A, Schiavone M, Adeniji AO, De Palma A, Di Gennaro F, Emuveyan EE, Grasso S, Henwood PC, Koroma AP, Leopold S, Marotta C, Marulli G, Putoto G, Pisani E, Russel J, Serpa Neto A, Dondorp AM, Hanciles E, Koroma MM, Schultz MJ. Lung Ultrasound for Detection of Pulmonary Complications in Critically Ill Obstetric Patients in a Resource-Limited Setting. Am J Trop Med Hyg. 2020 Dec 14;104(2):478-486. doi: 10.4269/ajtmh.20-0996.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lung ultrasound; critically ill peripartum; critically ill gynecological cases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: FMASU R148/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No