Ultrasound-Guided Diaphragmatic Thickness Assessment as an Indicator of Successful Extubation in Mechanically Ventilated

NCT03894436 | Completed

• 1 other identifier: IRB00004025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Weaning of mechanically ventilated patient is a daily challenge in Intensive Care units. Several indexes have been employed to assess the patient's ability to recover efficient spontaneous breathing. As the diaphragm is the main respiratory muscle, direct measurement of diaphragmatic function as predictors of extubation success or failure have not been extensively evaluated. Ultrasound can easily access diaphragm thickness (tdi) in its zone of apposition during, tdi can represent the contractile activity of the diaphragm and the efficiency of its function.

Conditions

Successful Weaning; Weaning Failure

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of diaphragm thickness compared to ABG as standard for weaning

  diagnostic accuracy of diaphragm thickness to predict weaning compared to ABG

  6 months

• Sensitivity and specificity of diaphragm delta tdi compared to ABG as standard for weaning

  diagnostic accuracy of diaphragm delta tdi to predict weaning compared to ABG

  6 months

Secondary Outcomes (1)

• Sensitivity and specificity of RSBI compared to ABG as gold standard for weaning

  6 months

Interventions

Ultrasound assessment of diaphragm thickness in B-mode COMBINATION_PRODUCT

assess the thickness of diaphragm needed as a tool for prediction of extubation and proper timing of weaning from mechanical ventilation in the ICU which is measured by B mode ultrasound in ventilated cancer patients

Also known as: Rapid shallow breathing index, Arterial blood gases

Eligibility Criteria

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

Study Population

Fifty patients were recruited during the immediate postoperative period after major elective cancer surgery who needed mechanical ventilation (MV) due to a respiratory cause and met criteria for a spontaneous breathing trial with pressure support ventilation and diaphragm thickness is assessed by using b-mode ultrasound.

You may qualify if:

• Age18-65 years.
• ASA class 1 to 3,
• body mass index (BMI) between 20 and 40 kg/m2
• intubation for ≥ 48 hours
• Types of abdominal cancer surgery included partial gastrectomy, hysterectomy, Splenectomy, hepatectomy, and colectomy.

You may not qualify if:

• Hemodynamic instability requiring vasopressors.
• Gas exchange impairment requiring positive end-expiratory pressure (PEEP) \>10 cmH2O and/or FIO2 \> 50% to obtain a PaO2 \> 60 mmHg.
• Pressure support (PS) level \> 20 cmH2O.
• Body temperature \> 38°C or \< 35°C.
• Deep sedation state (RASS score \< -1).
• History of chronic obstructive pulmonary disease, neuromuscular disease, anatomical malformation of the diaphragm, or use of muscle paralyzing agents, aminoglycosides and corticosteroids.
• Pneumothorax or pneumomediastinum, increase intrabdominal pressure.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Ahmed Mohamed Soliman

Giza, Egypt

Location

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assestant lecturer of anaesthesia,icu and pain management

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: January 30, 2018
• Primary Completion: August 25, 2018
• Study Completion: November 21, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

EG (1)