Weaning Ventilator Using Heart, Lung And Diaphragm Ultrasound

Ultrasound Clinical Trial

Official title:

The Predictive Value Of Heart, Lung And Diaphragm Ultrasound For Ventilator Weaning Outcome Of Surgical Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321848
• Other study ID #: DUCGM2426
• Status: Recruiting
• Start date: April 22, 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Hanoi Medical University
• Contact: Duc Tran, MD
• Phone: +84983817388
• Email: ductran.hmu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Postextubation distress is detrimental to the prognosis of critically ill patients with successful spontaneous breathing trial. Failure to wean is known to be connected with heart, lung, and diaphragm problems. The aim of this study was to investigate how a composite model comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning outcome.

Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected along with clinical data about the patients. Either the successful weaning group or the failed weaning group is going to comprised the patients. Multivariate logistic regression analysis is going to be used to identify the variables that may be associated with the likelihood of weaning failure. A multiindicator combination model is going to be developed to increase the predictive accuracy after the possible indicators' accuracy in foretelling the weaning outcome was assessed.

Description:

• Research participants: From March 2024 to March 2026 in the Department of Anesthesia, critical care and pain medicine, Hanoi Medical University Hospital, patients ages over 18 years who will have mechanically ventilated for over 48 h will be recruited. Patients will be excluded if they had a diagnosis of progressive neuromuscular diseases, a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma), patients with thoracic surgery and mitral valve surgery. All patients and their families signed informed consents.

• Clinical data collection: Clinical data including gender, age, body mass index, primary disease, length of stay in ICU, duration of mechanical ventilation, acute physiology and chronic health evaluation II, Charlson Comorbidity Index, history of surgery/internal diseases will be collected.

• Spontaneous breathing trial (SBT): Patients will be undergone a 60-min SBT when they meet all the readiness weaning criteria with PS 7cmH2O, PEEP 5cmH2O, FiO2 40%. The vital signs, rapid shallow breathing index (RSBI), NIF, P0.1, tidal volume, respiratory rate, arterial blood gases will be recorded at the beginning and at the end of SBT.

GE Logiq P7 (GE Healthcare, USA) and Philips Affiniti 70G (Philips Ultrasound, USA) ultrasound diagnostic instruments will be used in this study. The heart, lung and diagphragm ultrasonic findings will be recorded by the sonographer well trained in point-of-care ultrasound at the begining and at the end of the SBT.

Tracheal extubation is carried out if the patient does not exhibit symptoms of intolerance, indicating that the SBT treatment was successful. In case intolerance symptoms manifest, return to the initially chosen breathing mode (SIMV, A/C) and record the SBT failure.

• Extubation: After successful SBT: proceed with extubation. The patient is given an oxygen mask at 5L/minute. If the patient does not show intolerance symptoms within 48 hours, the extubation is considered successful. If the patient develops one of the intolerance symptoms during this time period, the extubation failure will be recorded and the patients will be reintubated. Record the values of vital signs and arterial blood gas variables every 24, 48 hours after extubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18

• The duration of postoperative mechanical ventilation >= 48 hours

Exclusion Criteria:

• Patient had a diagnosis of progressive neuromuscular diseases

• Patient had a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma)

• Patients had thoracic surgery or mitral valve surgery.

Related Conditions & MeSH terms

• Ultrasound
• Ventilator Weaning

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ventilator weaning outcome	The outcome of weaning ventilation process (successful or failure)	after 48 hours of extubation
Secondary	The hospital length of stay	The time between hospital admission and discharge	Approximately 5-15 days postextubation
Secondary	The ICU length of stay	The time between ICU admission and discharge	Approximately 2-15 days postextubation
Secondary	The duration of mechanical ventilation	The time from the start of mechanical ventilation to extubation	Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months