Efficacy of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Prediction of Successful Weaning

May 11, 2026 updated by: Eman Diaa ElDin Hassan AlHassanin

Effectiveness of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Predicting Successful Extubation

the aim of this prospective cross-sectional study is Assessment the effectiveness of the RR/DTF in predicting successful extubation . and to Compare the effectiveness of the RR/DTF with conventional parameters (RSBI, VC, PIMAX) for predicting successful extubation

All participants will undergo a SBT by using pressure support ventilation (PSV) with pressure support of 5 cm H2O and positive end-expiratory pressure (PEEP) of 5 cm water (H2O) .

The decision to start weaning, extubation or reintubation will be made based on the attending physician's discretion following local guidelines. Daily, patients will be assessed by the attending physician for weaning readiness. Investigators will be informed when the ICU attending decide to extubate.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

this study will be carried out on mechanically ventilated patients in medical and surgical intensive care units (ICU) at Banha University Hospitals.

Each Patient after taking an informed consent will be subjected to:

  1. Full history taking including:

    Personal, present, past, family, and surgical histories of the patients will be documented. This includes collecting information about the patient's demographics, current health status, medical history, family medical history, length of mechanical ventilation(MV) until SBT, underlying disease, cause of respiratory failure and any prior surgical procedures.

  2. Clinical Examination:

    A thorough clinical examination of the patients will be conducted to evaluate their general health and assess any physical signs and symptoms related to the cause of admission or other conditions. Respiratory rate will be examined as well.

  3. Laboratory Investigations:

    Routine laboratory investigations will be carried out, including:

    Complete Blood Count (CBC). Coagulation studies, including Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and International Normalized Ratio (INR). Renal function tests, including Urea and Creatinine levels. Liver function tests, including Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT).

  4. Procedures:

SBT

Measurements:

Exhaled tidal volume(VT), RR, RSBI, vital capacity (VC) , PIMAX, and diaphragmatic parameters will be measured in all participants at 2 h after the SBT. VT will be calculated as minute ventilation divided by RR. The RSBI will be obtained by dividing RR (breaths/min) with tidal volume (litres). Measurement of vital capacity will be performed in the upright position after measurement of minute ventilation. PIMAX will be obtained by occluding the airway at end-expiration through a unidirectional valve, a calibrated device attached to the end of an endotracheal tube. PIMAX will be the most negative pressure documented after airway occlusion when patients will be instructed to take a maximal inspiratory effort against the closed valve. Transthoracic ultrasonography will be performed at the bedside with patients in a semi-recumbent position with the head of the bed at 30- 45 degrees from three consecutive tidal breaths on each side of the hemidiaphragm, and average values will be used for analysis. The diaphragm thickening fraction (DTF) percentage will be calculated with the following formula: thickness at the end of inspiration minus thickness at the end of expiration, divided by thickness at the end of expiration, then multiplied by 100. The RR/DTF will be calculated by dividing the respiratory rate (RR) by the DTF.

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

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

Study Locations

  • Egypt
      • Banhā, Egypt, 6460001
        • Benha Uneversity

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

mechanically ventilated patients in medical and surgical intensive care units

Description

Inclusion Criteria:

  • Age > 18 years old.
  • Both sexes will be included.
  • Patients with acute respiratory failure caused by medical or postoperative conditions who had been receiving MV for more than 48 h and tolerated 2 h spontaneous breathing trial (SBT)
  • Readiness for weaning from MV (recovery from the cause of respiratory failure, hemodynamic stability in the absence of vasopressors, and no administration of neuromuscular blocking agents or sedative drugs for more than 24 h prior to enrollment).

Exclusion Criteria:

  • History of neuromuscular disease or thoracic surgery.
  • Pneumothorax.
  • Presence of ascites.
  • Tracheostomized patients.
  • Poor image quality.
  • Spinal cord injury.
  • Arrhythmias.
  • Hemodynamic instability.

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

Outcome Measure
Measure Description
Time Frame
assessing the diagnostic accuracy of the respiratory rate/diaphragmatic thickening fraction that is measured by diaphragmatic ultrasound in predicting successful extubation from mechanical ventilation
Time Frame: 2 years
• The diaphragm thickening fraction (DTF) will be measured by using linear probe at the anterior axillary line with the transducer placed at the intercostal space between the 7th and 8th, or 8th and 9th ribs.Then (DTF) percentage will be calculated with the following formula: thickness at the end of inspiration minus thickness at the end of expiration,divided by thickness at the end of expiration, then multiplied by 100. The RR/DTF will be calculated by dividing the respiratory rate (RR) by the DTF.
2 years

Collaborators and Investigators

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

Sponsor

Eman Diaa ElDin Hassan AlHassanin

Investigators

  • Principal Investigator: Eman AlHassanin, MS, Benha University

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 (Actual)

May 12, 2024

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • md6-5-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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