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Completed

NCT Number: NCT06461754

Prediction of Successful Liberation From Invasive Mechanical Ventilation Via Lung and Diaphragmatic Ultrasound in Intensive Care Unit Patients, Prospective, Observational Study

Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Diaphragmatic and lung sonographic parameters (pulmonary scores) recently became the hot spot to help in anticipation of liberation from IMV.The aim of this study was to ensure that, sonographic diaphragmatic thickening indices and lung scores are reliable and accurate additional tools to anticipate successful liberation from IMV in intensive care unit (ICU) patients.

Methods: This study was a prospective, observational study conducted at Sohag university hospital on 80 patients admitted to the Intensive Care Unit (ICU) and mechanically ventilated invasively for more than 24 hours and they were ready for weaning by standard methods. At the time of spontaneous breathing trials (SBT), we did diaphragm and lung ultrasound, where we applied diaphragmatic thickening indices (DTI) and a modified lung ultrasound scores (LUSm). Patients classified into two groups; failed group (FG) and (SG) of liberation from IMV. Comparison between (FG) and (SG) in relation to pulmonary scores (DTI and LUSm) were recorded. Cut-off values, sensitivity and specificity for DTI and LUSm were obtained. Also, comparison between (FG) and (SG) in relation to demographic, clinical and respiratory data were assessed and all data were statistically analysed.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University Hospital

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age, more than 24 hours on IMV, and prepared for weaning

Exclusion criteria

  • A spinal cord injury that exceeded T8, arrhythmias, heart failure, hemodynamic instability, terminal extubation, pregnancy, pneumothorax, pneumomediastinum, COPD, thoracostomy, chest injuries that impeded ultrasound, pleural lesions, or neuromuscular diseases

Treatment and study plan

Sonographic evaluation of diaphragm and lung

Other

While the patient in a semi-sitting position (20-40 degree), by ultrasound, the diaphragm thickness was measured in the zone of apposition, on the mid-axillary line among the 8th and 10th intercostal spaces, using a 7-10 MHz linear probe in (M) mode. at the end of expiration and at the end of inspiration by capturing nearly three images during spontaneous patient breathing. The average of three DTI measurements was calculated In lung ultrasound, 2-4 MHz convex ultrasound probe in (B) mode was employed. We implemented a modified LUSm in our investigation, which assessed four lung regions on each side.

Primary outcomes

  1. a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation

    Time frame: One year

    we reporte a cut-off value for DTI and LUSm below or above which the risk for failure of weaning can be predicted with a sensitivity persent and a specificity persent.

Secondary outcomes

  1. The correlations of DTI and LUSm with demographic, clinical and respiratory data

    Time frame: one year

    We recorded the relations of DTI and LUSm with demographic, clinical and respiratory data in prediction of succeeded liberation from IMV

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.