Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients

NCT ID: NCT06728709

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2026-03-01

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

Conditions

Obstetric Complication; Gynecologic Cancer; Lung Diseases; Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

obstetrics critically ill

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

ultrasound detection of any abnormal ultrasonographical findings.

Intervention Type: DIAGNOSTIC_TEST

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

ultrasound detection of any abnormal ultrasonographical findings.

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wessam selima, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain shams university

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

wessam selima, MD

Role: CONTACT

w.z.selima@gmail.com

01001958858

Facility Contacts

Anesthesia department

Role: primary

anesth_office@med.asu.edu.eg

010009499962

References

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.

Reference Type: BACKGROUND

PMID: 37218800 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33319731 (View on PubMed)

Other Identifiers

FMASU R148/2024

Identifier Type: -

Identifier Source: org_study_id