Diaphragmatic Dysfunction in Critically Ill Patients Clinical Trial
Official title:
Diaphragmatic Ultrasound in Critically Ill Patients With Therapeutic Theophylline Trials
Critically ill patients are a group of patients with special needs during hospitalization.
The vast majority of them is mechanically ventilated and requires continuous assessment of
vital parameters.
It is quite impressive that assessment of respiratory muscles, and specifically of the
diaphragm, is lacking in the daily practice of ICU.
The diaphragm-the main inspiratory muscle-is considered so important in ICU. A lot of time in
ICUs is spent on weaning patients from mechanical ventilation. Although weaning from
mechanical ventilation can be a rapid and uneventful process for the majority of the
patients, it can be difficult in as many as 20-30% of them (1)(2). It is during weaning that
the diaphragm becomes the major pathophysiological determinant of weaning failure or success.
Weaning failure is defined as failing a spontaneous breathing trial or developing a
post-extubation respiratory distress that requires re-intubation or non-invasive ventilation
within 48 h following extubation (3).
So, identification of reliable predictors of weaning failure may represent potential avenues
of treatment that could reduce the incidence of weaning failure and its associated morbidity.
Known predictors of weaning failure include chronic obstructive airway disease (3), cardiac
failure(4-6), lung de-recruitment (7), pneumonia (8) and diaphragmatic dysfunction (9).
Rapid shallow breathing index (RSBI) is a clinical predictor of failure of weaning from
mechanical ventilation and it is widely used in clinical research and in practice (10).
However, diaphragmatic ultrasonography could be a promising tool for predicting reintubation
within 48 hours of extubation. As it permits direct assessment of diaphragm function.
It should be mentioned that diaphragmatic dysfunction among patients hospitalized in the
intensive care unit (ICU) is commonly attributed to critical illness polyneuropathy and
myopathy. Mechanical ventilation, even after a short period of time, can also induce
diaphragmatic dysfunction.
Recent researches have shown that theophylline improves diaphragmatic contractility in
isolated muscle preparations in animals and in normal human subjects. The question now does
the theophylline have a significant role in critical ill patients with diaphragmatic
dysfunction whether they are diabetic or not ?
| Status | Not yet recruiting |
| Enrollment | 46 |
| Est. completion date | June 2022 |
| Est. primary completion date | April 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The inclusion criteria are as follows: critical ill patients that are admitted to our ICU whether they are mechanically ventilated or not . Exclusion Criteria: - exclusion criteria are the presence of pneumothorax or ascites, a history of either neuromuscular disease or thoracic surgery, congenital diaphragmatic hernia, the presence of a tracheostomy tube,chronic obstructive pulmonary disease (COPD) patients, asthma and poor image quality. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | how much improvement in diaphragmatic thickness and excursion after theophylline treatment. | how much improvement in diaphragmatic thickness and excursion after theophylline treatment. | Baseline | |
| Secondary | number of successful weaning trials based on diaphragmatic ultrasound findings | number of successful weaning trials based on diaphragmatic ultrasound findings | Baseline |