Diaphragmatic Ultrasound With Theophylline Therapeutic Trials

NCT04269187 | Unknown Early Phase 1

• 1 other identifier: DUS in critically ill patients
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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 ?

Conditions

Diaphragmatic Dysfunction in Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

• how much improvement in diaphragmatic thickness and excursion after theophylline treatment.

  how much improvement in diaphragmatic thickness and excursion after theophylline treatment.

  Baseline

Secondary Outcomes (1)

• number of successful weaning trials based on diaphragmatic ultrasound findings

  Baseline

Study Arms (2)

With theophylline treatment

EXPERIMENTAL

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.

Drug: Theophylline

No theophylline treatment

NO INTERVENTION

This group will be for: diaphragmatic ultrasound after admission to ICU then reassessment of diaphragm by ultrasound before discharge

Interventions

Theophylline DRUG

Theophylline oral 200 mg daily for 12 days

With theophylline treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 7921460 BACKGROUND

• 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.

  PMID: 27112953 BACKGROUND

Related Links

• Related Info
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MeSH Terms

Interventions

Theophylline

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hanan Sharaf ElDin, Lecturer

  Assiut university; internal medicine department

  STUDY DIRECTOR

• Sahar Farghaly, Lecturer

  Assuit university; chest diseases department

  STUDY DIRECTOR

• Hanan Mahmoud, Professor

  Assuit university; internal medicine department

  STUDY DIRECTOR

Central Study Contacts

Doaa Roshdy Abdul satar

CONTACT

01024588594; doaa.elenany@Yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 13, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 13, 2020

Record last verified: 2020-02