Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients

Recruiting

• Conditions: Obstetric Complication; Gynecologic Cancer; Lung Diseases; Ultrasound

• Registration Number: NCT06728709
• Lead Sponsor: Ain Shams University

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 Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-11
• Study Start: 2024-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-03-25
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Prevalence of different ultrasonographical abnormal lung signatures	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 Outcome Measures

Name	Time	Method
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	the time of detection of the abnormal lung ultrasonographic finding
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	frequency of occurrence of poor outcomes -mortality or ventilatory support- for every abnormal lung ultrasonographic signature.

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt