Extubation SuccessNCT06945952
Efficacy of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Prediction of Successful Weaning
An observational study of Extubation Success, run by Eman Diaa ElDin Hassan AlHassanin at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Success
- What is being tested?
- diaphragmatic ultrasonography
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mechanically ventilated patients in medical and surgical intensive care units
Who may be able to join
- 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).
Who cannot join
- History of neuromuscular disease or thoracic surgery.
- Pneumothorax.
- Presence of ascites.
- Tracheostomized patients.
- Poor image quality.
- Spinal cord injury.
- Arrhythmias.
- Hemodynamic instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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).
- 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.
- Conditions
- Extubation Success
- Being tested
- diaphragmatic ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic ultrasonographyDevice
using diaphragmatic ultrasonography to measure diaphragmatic thickening fraction and then calculate the ratio RR/DTF
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start12 May 2024
- Primary completion15 Jun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation SuccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Diaa ElDin Hassan AlHassanin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Diaa ElDin Hassan AlHassanin, Benha University
- Investigators
- Eman AlHassanin, MS, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945952
- Sponsor's protocol ID
- md6-5-2024
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2025
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Predicting Successful Extubation
- ClinicalTrials.gov ID
- NCT06945952
- Acronym / sponsor ID
- md6-5-2024
- Conditions
- Extubation Success
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Eman Diaa ElDin Hassan AlHassaninUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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).
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechanically ventilated patients in medical and surgical intensive care units
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- History of neuromuscular disease or thoracic surgery.
- Pneumothorax.
- Presence of ascites.
- Tracheostomized patients.
- Poor image quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragmatic ultrasonographyusing diaphragmatic ultrasonography to measure diaphragmatic thickening fraction and then calculate the ratio RR/DTF | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Extubation Success
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation
High Velocity Nasal Insufflation, Simple Oxygen
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
Not yet recruitingObservational study
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
Extubation Success, Extubation Failure
Not yet recruitingObservational study
Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing
Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman AlHassanin, MS principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation Success, run by Eman Diaa ElDin Hassan AlHassanin at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.