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

NCT ID: NCT06461754

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-21

Study Completion Date

2023-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Liberation From Mechanical Ventilation in ICU Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Succeeded Group (SG)

Group of patients who succeeded weaning from mechanical ventilation

Sonographic evaluation of diaphragm and lung

Intervention Type 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.

Failed Group (FG)

Group of patients who failed weaning from mechanical ventilation

Sonographic evaluation of diaphragm and lung

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Fawzy Abbas Badawy

Assistant lecturer of anesthesia,intensive care and pain management sohag faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 29911284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34007779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27112953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24949192 (View on PubMed)

Other Identifiers

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Soh-Med-22-09-20

Identifier Type: -

Identifier Source: org_study_id

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