Clinical trial NCT05063526: The Role of Diaphragmatic Ultrasound as a Predictor of Extubation From Mechanical Ventilation
Official title: The Role of Diaphragmatic Ultrasound as a Predictor of Successful Extubation From Mechanical Ventilation in Respiratory Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Ultrasound
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective study was carried out on 40 patients who are mechanically ventilated due to pulmonary disease, 40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU and 40Chronic obstructive pulmonary disease (COPD) patients from Outpatient Clinic serving as controls at Embaba Chest Hospital. Cairo, Egypt during a period from January 2018 to November 2019. Written informed consent was obtained from all patients prior to enrollment according to approval at the local committee of Beni-suef University Hospital.

Brief 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.

Detailed 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

Eligibility criteria: 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 .

Primary outcomes:
measure: diaphragmatic ultrasound thickening
timeFrame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
measure: diaphragmatic ultrasound thickening fraction
timeFrame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
measure: diaphragmatic ultrasound excursion
timeFrame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Secondary outcomes:
measure: diaphragmatic ultrasound thickening fraction
timeFrame: Up to 48 hours on T-tube, through study completion, an average of 1 year
measure: diaphragmatic ultrasound thickening
timeFrame: Up to 48 hours on T-tube, through study completion, an average of 1 year
measure: diaphragmatic ultrasound excursion
timeFrame: Up to 48 hours on T-tube, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef
state: Mequbal
Study officials:
affiliation: Benisuef unviresity
name: Randa S Mohamed, professor
role: STUDY_DIRECTOR
References:
citation: Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra 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.
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.
citation: 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.
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.