Diaphragmatic Ultrasound With Theophylline Therapeutic Trials
Primary Purpose
Diaphragmatic Dysfunction in Critically Ill Patients
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Theophylline
Sponsored by
About this trial
This is an interventional treatment trial for Diaphragmatic Dysfunction in Critically Ill Patients
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
With theophylline treatment
No theophylline treatment
Arm Description
This group will be for: diaphragmatic ultrasound after admission to ICU and before administration of theophylline; 200 mg/d orally for 12 days then reassessment of diaphragm by ultrasound.
This group will be for: diaphragmatic ultrasound after admission to ICU then reassessment of diaphragm by ultrasound before discharge
Outcomes
Primary Outcome Measures
how much improvement in diaphragmatic thickness and excursion after theophylline treatment.
how much improvement in diaphragmatic thickness and excursion after theophylline treatment.
Secondary Outcome Measures
number of successful weaning trials based on diaphragmatic ultrasound findings
number of successful weaning trials based on diaphragmatic ultrasound findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04269187
Brief Title
Diaphragmatic Ultrasound With Theophylline Therapeutic Trials
Official Title
Diaphragmatic Ultrasound in Critically Ill Patients With Therapeutic Theophylline Trials
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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 ?
Detailed Description
All patients will be subjected to:
medical history.
clinical examination.
diaphragmatic ultrasound : diaphragmatic thickness and excursion will be assessed.
theophyllin treatment; 200 mg/d orally for 12 days then reassessment of diaphragm by ultrasound.
weaning trial ; Patients are considered ready for weaning when they meet all the following criteria: fraction of inspired oxygen (FiO2) < 0.5, positive end expiratory pressure (PEEP) ≤ 5 cm water , Pa O2/Fi O2> 200, respiratory rate (RR) <30 breaths/min, alert and cooperative, and hemodynamically stable in the absence of any vasopressor therapy support.(11)
rapid shallow breathing index (RSBI) will be measured. It's defined as the ratio between the respiratory rate (breaths/min) and tidal volume (TV) (liters).
2-hour spontaneous breathing trial with a T-piece and zero pressure support (before extubation).
extubation is done & follow up for 48 hours
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragmatic Dysfunction in Critically Ill Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With theophylline treatment
Arm Type
Experimental
Arm Description
This group will be for: diaphragmatic ultrasound after admission to ICU and before administration of theophylline; 200 mg/d orally for 12 days then reassessment of diaphragm by ultrasound.
Arm Title
No theophylline treatment
Arm Type
No Intervention
Arm Description
This group will be for: diaphragmatic ultrasound after admission to ICU then reassessment of diaphragm by ultrasound before discharge
Intervention Type
Drug
Intervention Name(s)
Theophylline
Intervention Description
Theophylline oral 200 mg daily for 12 days
Primary Outcome Measure Information:
Title
how much improvement in diaphragmatic thickness and excursion after theophylline treatment.
Description
how much improvement in diaphragmatic thickness and excursion after theophylline treatment.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
number of successful weaning trials based on diaphragmatic ultrasound findings
Description
number of successful weaning trials based on diaphragmatic ultrasound findings
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Roshdy Abdul satar
Phone
01024588594
Email
doaa.elenany@Yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanan Sharaf ElDin, Lecturer
Organizational Affiliation
Assiut university; internal medicine department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sahar Farghaly, Lecturer
Organizational Affiliation
Assuit university; chest diseases department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanan Mahmoud, Professor
Organizational Affiliation
Assuit university; internal medicine department
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
7921460
Citation
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. doi: 10.1164/ajrccm.150.4.7921460.
Results Reference
background
PubMed Identifier
27112953
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/7921460/
Description
Related Info
URL
https://www.google.com/url?sa=t&source=web&rct=j&url=https://daneshyari.com/article/preview/5562965.pdf&ved=2ahUKEwitvd-7m73nAhWmRhUIHX_jCRQQFjAAegQIAxAB&usg=AOvVaw3dzzyX2YgXmojGd_nnAw97
Description
Related Info
Learn more about this trial
Diaphragmatic Ultrasound With Theophylline Therapeutic Trials
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