Exploring the Use of Pulse Tissue Doppler in Predicting Extubation Success in Mechanically Ventilated Patients

Sponsor
Affiliated Hospital of Jiangnan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06154811
Collaborator
(none)
200
1
27
7.4

Study Details

Study Description

Brief Summary

Determining the appropriate extubation timing for mechanically ventilated patients is a critical issue in the Intensive Care Unit (ICU). Early or delayed extubation may prolong mechanical ventilation and ICU stay, leading to an increased mortality rate. Currently, extubation timing relies solely on the Spontaneous Breathing Trial (SBT), but its reliability is relatively low, with a extubation failure rate ranging from 10% to 40%. Therefore, accurately predicting potential post-extubation issues and early identification of reasons for SBT trial failure are crucial for improving patient outcomes. Commonly used parameters for assessing readiness for extubation do not fully reflect organ dysfunction, and we plan to utilize comprehensive techniques, including bedside lung and diaphragm ultrasound parameters, to enhance the accuracy of predicting extubation outcomes in patients who pass the SBT trial.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All mechanically ventilated (MV) patients admitted to the ICU from September 01, 2022, to December 30, 2024, will be continuously enrolled, provided they meet the following inclusion criteria: (a) Resolution or improvement of the condition that led to the MV; (b)Adequate level of consciousness without sedation ; (c) systolic blood pressure of 90-160 mmHg (no or minimal vasopressor); (d) absence of excessive tracheobronchial secretions; (e) stable metabolic status; (f) Sufficient lung function, indicated by RR<30 breaths/min with VT≥5 mL/kg ideal body weight(IBW)and no significant respiratory acidosis; (g)adequate oxygenation, as indicated by arterial oxygen saturation (SaO2)>90% with inspired oxygen fraction (FiO2)≤0.5, or arterial oxygen partial pressure to inspired oxygen fraction (PaO2/FiO2)≥150 mmHg, both with positive end-expiratory pressure (PEEP)≤9 centimeters of water(cmH2O); Exclusion criteria included:(a) paralytic drugs taken within 24 hours prior to the trial;(b)diagnosis of diaphragmatic paralysis or paradoxical movement of the hemidiaphragm detected by ultrasound or poor imaging quality.;(c)Pregnancy;(d)Ascites;(e)age<18years(f)Post-thoracotomy;(g)Existence of pneumothorax; (h)presence of large pleural effusion, subcutaneous emphysema, flail chest or right-sided rib fractures; and (i) presence of neuromuscular diseases.

    Evaluation of the diaphragm Pulse Wave(PW)-Tissue Doppler Imaging(TDI) PW-TDI measurements were obtained at the bedside with subjects in the semi-reclined position, using a portable ultrasound device equipped with a sector transducer (1.8-4.2MHz) and a dedicated cardiac Doppler application(Xario200,Canon Medical Systems, Zoetermeer, the Netherlands).One-sided evaluation of the right diaphragm is acceptable for critical illness, unless one side is suspected of malfunctioning (which requires bilateral evaluation).We chose to assess only the right diaphragm due to the known anatomical difficulties in visualising the left diaphragm.With the ultrasound beam perpendicular to the middle or posterior third of the membrane, the Tissue Doppler application has been turned on and a clear diaphragm signal has been obtained by gain fading and excluding high frequency signals.The maximum amplitude sample box (30 mm) was positioned on the membrane line after aligning the Doppler cursor with the direction of membrane displacement to measure its excursion.The scale of the spectral velocity has been reduced to include the upper range of the inspiratory and expiratory velocities. Special care was taken to ensure that the PW-TDI traces were recorded during as regular a breathing pattern as possible. At least 3 breathing cycles were averaged.

    Diaphragmatic ultrasonography measurements Expiratory diaphragm thickness (TEE) and inspiratory diaphragm thickness (TEI) were measured, and the thickening fraction (TF) was calculated using the formula TF=(TEI-TEE)/TEE. Simultaneously, diaphragmatic excursion (DE) and the diaphragmatic excursion rapid shallow breathing index (D-RSBI) were assessed, where D-RSBI is calculated as the ratio of respiratory rate (RR) to diaphragmatic excursion (DE).

    Quantitative Lung Ultrasound In our study, we used a modified procedure (LUSm).Four areas were evaluated: anterior-superior, anterior-inferior, lateral and postero-basal.Overall LUSm scores for all domains were between 0 and 24 points.

    Assess the reproducibility of ultrasound parameters Thirty patients were selected at random for the assessment of the reproducibility.In the interobserver reproducibility study, two intensivists (LJ and LD) measured PW-TDI and LUSm in the same sample of patients. The time difference between the two operators was less than 30 minutes. The operators were blinded to the results of the other operator. One of the operators (LJ) repeated the measurement 5 min after the initial measurement to assess intra-observer reproducibility.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predicting Extubation Outcomes in Mechanically Ventilated Patients Using PW-TDI Diaphragmatic Kinematics and Traditional Ventilation Parameters: A Prospective Study
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Extubation Success Group

    Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation.

    Extubation Failure Group

    Extubation failure is defined as successful Spontaneous Breathing Trial (SBT) but an inability to sustain independent breathing for more than 48 hours without non-invasive or invasive ventilation.

    Outcome Measures

    Primary Outcome Measures

    1. Successful Removal of Endotracheal Tube [The patient undergoes a spontaneous breathing trial, and measurements are taken 30 minutes after the removal of the endotracheal tube.]

      Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients were enrolled if they had been intubated and mechanically ventilated for more than 24 hours and were ready for their first SBT according to ICU weaning criteria.
    Exclusion Criteria:
    • paralytic drugs taken within 24 hours prior to the trial;

    • diagnosis of diaphragmatic paralysis or paradoxical movement of the hemidiaphragm detected by ultrasound or poor imaging quality;

    • Pregnancy;

    • Ascites;

    • age<18years;

    • Post-thoracotomy;

    • Existence of pneumothorax;

    • presence of large pleural effusion, subcutaneous emphysema, flail chest or right-sided rib fractures;

    • presence of neuromuscular diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Hospital of Jiangnan University Wuxi Jiangsu China 214122

    Sponsors and Collaborators

    • Affiliated Hospital of Jiangnan University

    Investigators

    • Study Director: Jun Liu, Master, Affiliated Hospital of Jiangnan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Affiliated Hospital of Jiangnan University
    ClinicalTrials.gov Identifier:
    NCT06154811
    Other Study ID Numbers:
    • 269089632
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 4, 2023