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Completed

NCT Number: NCT05295186

Non-invasive Respiratory Monitoring During SBT

Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Currently, non-invasive techniques allow comprehensive bedside assessment of advanced respiratory mechanics, including metrics of respiratory system compliance (CRS), respiratory muscle effort (POCC) and respiratory drive intensity (P0.1). This study investigates whether these measurements during SBT may improve the prediction of extubation outcomes

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Policlinico, Bari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be eligible, patients had to meet all of the following criteria:

  • Age ≥ 18 years.
  • The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning >2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.
  • Deemed ready to be weaned from the ventilator, based on the following criteria: (a) invasive mechanical ventilation for more than 48 hours, including at least 12 hours of pressure support ventilation with PEEP ≤ 8 cmH2O and pressure support ≤ 10 cmH2O; (b) Improvement of the condition leading to intubation; (c) patient making inspiratory effort; (d) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within normal range (7.30 - 7.50); (e) Glasgow Coma Score higher than 13; (f) a core temperature below 38°C; (g) Richmond agitation and sedation scale between -1 and +1.

Eligibility required readiness for scheduled extubation after successfully completing a 30-minute SBT in the pressure-support mode (7 cmH₂O)

SBT success was defined by the following criteria [19]: (a) adequate gas exchange, as indicated by a ratio of partial pressure of arterial oxygen (PaO2) to inspiratory fraction of oxygen (FiO2) ≥ 150 with FiO2 ≤ 40% and arterial pH within the normal range (7.30 - 7.50); (b) respiratory rate < 35/min; (c) spontaneous tidal volume higher than 5 ml of predicted body weight (PBW); (d) a ratio of respiratory rate to tidal volume (i.e. the rapid shallow breathing index, RSBI) < 105/min per liter; (e) systolic blood pressure between 90 and 160 mmHg and heart rate < 140/min, with or without low doses of vasopressors (< 0.5 mcg/kg/min). Exclusion criteria were tracheostomy, patients undergoing withdrawal of life-sustaining treatments, known neuromuscular diseases.

Treatment and study plan

Primary outcomes

  1. Advance Respiratory mechanics assessment during SBT

    Time frame: 30 minutes

    The primary endpoint was to establish whether changes in CRS, POCC and P0.1 and/or their absolute values at the end of the PAV+ SBT differed between patients who subsequently required reintubation vs. those who were successfully extubated

Secondary outcomes

  1. discriminatory power

    Time frame: 72 hours

    we aimed to test the discriminatory power of the absolute values of CRS, POCC and P0.1 at the end of SBT and discriminatory power of the SBT-induced percentage changes in these measurements during the trial in identifying patients who failed extubation.The decision to reintubate was made by the attending physicians, who were unaware of the study measurements results.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Collaborators

  • Catholic University of the Sacred Heart
  • University of Turin, Italy
  • Università degli Studi di Ferrara
  • Università degli Studi di Sassari

Registry information

Official study title

Noninvasive Assessment of Respiratory Mechanics, Inspiratory Effort, and Respiratory Drive During Spontaneous Breathing Trial to Predict Extubation Failure in High-Risk Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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