Clinical trial NCT06728709: Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients
Official title: Lung Assessment and Monitoring in Critically Ill Obstetrics and Gynecological Patients by Point of Care Ultrasound; Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstetric Complication
Gynecologic Cancer
Lung Diseases
Ultrasound
Keywords: lung ultrasound
critically ill peripartum
critically ill gynecological cases
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill women admitted in the ICU for any medical, obstetric, or surgical causes.

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

Eligibility criteria: 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

Primary outcomes:
measure: the Prevalence of different ultrasonographical abnormal lung signatures
timeFrame: From date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 days
Secondary outcomes:
measure: correlation of ultrasonographic finding with mortality or poor outcome
timeFrame: 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
measure: timing of appearance of abnormal ultrasonography lung signatures
timeFrame: 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
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Ain Shams University
name: wessam selima, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.