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

NCT06945952 | Active Not Recruiting FDA Device

• 1 other identifier: md6-5-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extubation Success

Outcome Measures

Primary Outcomes (1)

• assessing the diagnostic accuracy of the respiratory rate/diaphragmatic thickening fraction that is measured by diaphragmatic ultrasound in predicting successful extubation from mechanical ventilation

  • 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

Interventions

diaphragmatic ultrasonography DEVICE

using diaphragmatic ultrasonography to measure diaphragmatic thickening fraction and then calculate the ratio RR/DTF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

mechanically ventilated patients in medical and surgical intensive care units

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Eman Diaa AlDin Hassan AlHassanin: lead

Study Sites (1)

Benha Uneversity

Banhā, 6460001, Egypt

Location

Study Officials

• Eman AlHassanin, MS

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 27, 2025
• Study Start: May 12, 2024
• Primary Completion: March 12, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

EG (1)