NCT05947942

Brief Summary

The study aims to compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 9, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thoracic fluid content by electrical cardiometry versus diaphragmatic excursion by Ultrasound for prediction of weaning success in patients with lung congestion

    compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.

    1 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will be conducted on 100 patients admitted to critical care department at Benha university hospitals with lung congestion. Patients who are candidate for weaning from invasive mechanical ventilation (after 48 h) and who agree to participate in the study will be involved.

You may qualify if:

  • Patients of both genders aged 18-70 years old.
  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score
  • Patients with congested lung including; Acute exacerbation of COPD patients with acute respiratory failure (PaO2/FiO2 ratio ≤300 or PaCO2 ≥ 50 mm Hg at intubation), pneumonia, chronic kidney disease, heart failure (New York Heart Association Classification III, IV) who will be candidate for weaning from invasive mechanical ventilation according to the treating physician's judgement using the ICU weaning protocol.

You may not qualify if:

  • Patients younger than 18 years or older than 70 years
  • Refusal to participate.
  • Obesity (BMI≥35).
  • Pregnancy.
  • Patients with pneumothorax, pleural, or pericardial effusion, lung contusion, and thoracotomy.
  • Hepatic dysfunction.
  • history or new detection of paralysis (no movement) or paradoxical movement of a single hemidiaphragm.
  • preexisting cervical spinal injury, history of neuromuscular disorders
  • Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes will be also excluded from the study.
  • Mechanical ventilation \< 48 hrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shawky meselhi shawky

Cairo, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

May 20, 2023

Primary Completion

March 20, 2024

Study Completion

April 20, 2024

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations