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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05063526
Other study ID # FMBSUREC/05012020/Ahmed
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date November 1, 2019

Study information

Verified date October 2021
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim: To evaluate real-time ultrasound in the evaluation of diaphragmatic thickening, thickening fraction and or excursion to predict extubation outcomes. The investigators aimed to compare these parameters with other traditional weaning measures.


Description:

The diaphragm is an important respiratory muscle and dysfunction is very common in patients receiving mechanical ventilation. Diaphragm fatigue occurs even in patients who successfully pass the Spontaneous Breathing Test (SBT). Interrupting ventilation too early can lead to increased cardiovascular and respiratory pressure (CO2).retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support. Unnecessary delays in liberation from mechanical ventilation also can be deleterious. Complications such as ventilator-associated pneumonia and ventilator-induced diaphragm atrophy can be seen with short periods of mechanical ventilation thereby prolonging mechanical ventilation. As SBT monitoring is insensitive to detect early signs of load-capacity imbalance. The evaluation of the diaphragmatic thickening fraction (DTF) may be also helpful to assess diaphragmatic function and its contribution to respiratory workload. Ultrasound can be used to detect the deflection of the diaphragm, which helps to identify patients with diaphragm dysfunction


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 1, 2019
Est. primary completion date January 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Critically ill patients intubated for more than 48 hours who are ready for weaning with the following criteria. 1. positive end-expiratory pressure (PEEP) = 5 cm H2O. 2. Fraction of inspired oxygen (FiO2) < 0.5. 3. respiratory rate (RR) < 30 breaths/min. 4. rapid shallow breathing index < 105, PaO2/FiO2 > 200. - Age< 65 years. Exclusion Criteria: - Age<18 years. - Patient with history of plural effusion, trauma to chest and history of mechanical ventilation for < 6 months. - patient with neuromuscular diseases affect diaphragm .

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasound
ultrasound on diaphragm

Locations

Country Name City State
Egypt Beni-suef Bani Suwayf Mequbal

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22. — View Citation

Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Aprà F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014. — View Citation

Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638. — View Citation

Umbrello M, Formenti P. Ultrasonographic Assessment of Diaphragm Function in Critically Ill Subjects. Respir Care. 2016 Apr;61(4):542-55. doi: 10.4187/respcare.04412. Epub 2016 Jan 26. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary diaphragmatic ultrasound thickening Right diaphragmatic ultrasound measurement thickening in millimeter was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Primary diaphragmatic ultrasound thickening fraction Right diaphragmatic ultrasound measurement thickening fraction(percentage% ) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Primary diaphragmatic ultrasound excursion Right diaphragmatic ultrasound measurement excursion( centimeter) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Secondary diaphragmatic ultrasound thickening fraction Differences in thickening fraction ( millimeter )between patients who are successfully and failed weaning . Up to 48 hours on T-tube, through study completion, an average of 1 year
Secondary diaphragmatic ultrasound thickening Differences in diaphragm thickening(percentage% )between patients who are successfully and failed weaning . Up to 48 hours on T-tube, through study completion, an average of 1 year
Secondary diaphragmatic ultrasound excursion Differences in diaphragm excursion ( centimeter) between patients who are successfully and failed weaning Up to 48 hours on T-tube, through study completion, an average of 1 year
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