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Clinical Trials/NCT06728709
NCT06728709CompletedNot Applicable

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

Ain Shams University2 sites in 1 country280 target enrollmentStarted: December 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
280
Locations
2
Primary Endpoint
the Prevalence of different ultrasonographical abnormal lung signatures

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts 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

Arms & Interventions

obstetrics critically ill

critically ill obstetrics patients admitted yo ICU for any cause during pregnancy or postpartum.

Intervention: ultrasound detection of any abnormal ultrasonographical findings. (Diagnostic Test)

gynecological critically ill patients

gynecological cases admitted to ICU for any cause of medical or postoperative care

Intervention: ultrasound detection of any abnormal ultrasonographical findings. (Diagnostic Test)

Outcomes

Primary Outcomes

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

  • correlation of ultrasonographic finding with mortality or poor outcome(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(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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