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.

Study Overview

• Status: Completed
• Conditions: Liberation From Mechanical Ventilation in ICU Patients
• Intervention / Treatment: Other: Sonographic evaluation of diaphragm and lung

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

80 patients who were admitted to the ICU and on invasive mechanical ventilation for more than 24 hours and ready for weaning

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Succeeded Group (SG); Group of patients who succeeded weaning from mechanical ventilation	Other: Sonographic evaluation of diaphragm and lung; 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.
Failed Group (FG); Group of patients who failed weaning from mechanical ventilation	Other: Sonographic evaluation of diaphragm and lung; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation	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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlations of DTI and LUSm with demographic, clinical and respiratory data	We recorded the relations of DTI and LUSm with demographic, clinical and respiratory data in prediction of succeeded liberation from IMV	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
• 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.
• Tenza-Lozano E, Llamas-Alvarez A, Jaimez-Navarro E, Fernandez-Sanchez J. Lung and diaphragm ultrasound as predictors of success in weaning from mechanical ventilation. Crit Ultrasound J. 2018 Jun 18;10(1):12. doi: 10.1186/s13089-018-0094-3.
• Gok F, Mercan A, Kilicaslan A, Sarkilar G, Yosunkaya A. Diaphragm and Lung Ultrasonography During Weaning From Mechanical Ventilation in Critically Ill Patients. Cureus. 2021 May 16;13(5):e15057. doi: 10.7759/cureus.15057.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-22-09-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No