Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.

October 1, 2022 updated by: Alaa Mohammed Taghyan, Assiut University

Evaluation of a Combined Model of Lung Aeration Score and Diaphragmatic Indices by Transthoracic Ultrasonography in Predicting Weaning Success in Critically Ill Patients.

The purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Assessment of lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success in critically ill patients .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study group will be mechanically ventilated for at least 48 hours. Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines and assessment of the three parameters which is Rapid shallow breathing index ( RSBI), lung ultrasound score( LUS) and Diaphragmatic ultrasound (DUS) will be done for predicting weaning success.

Description

Inclusion Criteria:

  • Patients more than18 years old.
  • All patients intubated and requiring mechanical ventilation for 48 hours or more at respiratory intensive care unit (RICU)
  • Patients fullfiled the criteria of readiness to wean according to European Respiratory Society guidelines (ERS)

Exclusion Criteria

  • Patients with neuromuscular disease or diaphragmatic paralysis.
  • Patients with tracheostomy.
  • Patients who undergone surgical operations especially abdominal and thoracic operation.
  • Patients with diseases that may affect the diaphragm (including pneumothorax, pneumomediastinum, patients with inserted intercostal tube (ICT), third trimester of pregnancy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of lung aeration by lung ultrasound score using MEDESION SONOACE R3 portable ultrasound apparatus in patients ready to be weaned from mechanical ventilation (MV) as a predictor of weaning success.
Time Frame: baseline
The lung ultrasound score (LUS) will be calculated according to the observed worst ultrasound pattern using the convex probe (MEDESION SONOACE R3 portable ultrasound, Korea 2010). (normal aeration, LUS = 0);( moderate loss of lung aeration (multiple, well-defined B lines), LUS = 1);( severe loss of lung aeration (multiple coalescent B lines), LUS = 2); (lung consolidation, LUS = 3).Finally, the LUSs of all the parts will added to obtain the total LUS for each patient (maximum36 points).
baseline
Assessment of diaphragmatic thickness by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
Time Frame: baseline
The diaphragmatic ultrasound will performed for assessment of diaphragmatic thickness by M-Mode Using the high frequency linear probe of 7.5 MHz.This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. DT difference (DTD) will be calculated by subtracting The Diaphragm thickening fraction (DTF) will calculated as: DTD/(DT at end-expiration) × 100%
baseline
Assessment of diaphragmatic motion by diaphragmatic ultrasonography M-mode in patients ready to be weaned from MV as a predictor of weaning success.
Time Frame: baseline
The diaphragmatic ultrasound will performed for assessment of diaphragmatic motion by M-mode using the curvilinear low frequency probe (5 MHz).This will done in serial manner beginning 24 hours after RICU admission,then during spontaneous breathing trial till the patient is liberated from mechanical ventilation. Diaphragmatic excursion (DE) will identified and measured. DE amplitude will measured on the vertical axis by tracing from the baseline to the point of maximum height of inspiration on the graph.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare between sonographic lung aeration assessment, diaphragmatic indices and rapid shallow breathing index(RSBI) as predictors for results of weaning from mechanical ventilation(MV)
Time Frame: baseline
Compare between sonographic lung aeration assessment, diaphragmatic indices and RSBI as predictors for results of weaning from MV and showing the predictive value for which parameter to predict weaning sucess alone or combining all three parameters together.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alaa M Taghyan, Ass.Lecturer, Chest department at Assuit university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • lung US in ICU patient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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