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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaphragmatic Dysfunction in Critically Ill Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 6, 2020
    Last Updated
    February 12, 2020
    Sponsor
    Assiut University
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    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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