Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients

NCT06728709 | Recruiting

• 1 other identifier: FMASU R148/2024
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Obstetric Complication; Gynecologic Cancer; Lung Diseases; Ultrasound

Keywords

lung ultrasound; critically ill peripartum; critically ill gynecological cases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

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.

Interventions

ultrasound detection of any abnormal ultrasonographical findings. 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; obstetrics critically ill

Eligibility Criteria

• Gender Eligibility Details: Pregnant, peripartum, or gynecological critical illness
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Any patient admitted to the obstetrics and gynecology intensive care unit

You may not qualify if:

• Patient's refusal
• inability to do a lung ultrasound examination during the first 24 hours of admission

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, 11528, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 37218800 BACKGROUND

• 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.

  PMID: 33319731 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• wessam selima, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wessam selima, MD

CONTACT

01001958858; w.z.selima@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: December 11, 2024
• Study Start: December 15, 2024
• Primary Completion: March 25, 2026
• Study Completion: April 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

EG (1)