Clinical trial NCT06321848: Weaning Ventilator Using Heart, Lung And Diaphragm Ultrasound
Official title: The Predictive Value Of Heart, Lung And Diaphragm Ultrasound For Ventilator Weaning Outcome Of Surgical Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventilator Weaning
Ultrasound
Keywords: echocardiography
lung ultrasound
diaphragm ultrasound
ventilator weaning
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a duration of mechanical ventilation through an endotracheal tube of more than 48 hours and meeting the criteria of readiness to wean off mechanical ventilation will be included in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The ventilator weaning outcome
timeFrame: after 48 hours of extubation
Secondary outcomes:
measure: The hospital length of stay
timeFrame: Approximately 5-15 days postextubation
measure: The ICU length of stay
timeFrame: Approximately 2-15 days postextubation
measure: The duration of mechanical ventilation
timeFrame: Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University Hospital
Study officials:
affiliation: Hanoi Medical University
name: Tu Nguyen, Professor
role: STUDY_DIRECTOR
References: