Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303, Turkey (Türkiye)
NCT Number: NCT07268989
The goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are:
Can the mechanical power (MP) value predict successful extubation? Do other respiratory parameters-airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)-provide additional prognostic value for weaning outcomes?
Participants will:
* Be adult ICU patients planned for weaning from mechanical ventilation. * Undergo bedside ventilatory assessment within 2 hours after meeting clinical weaning criteria. * Have the following respiratory parameters measured: MP, P0.1, NIF, and RSBI. * Be monitored for 48 hours after extubation to assess weaning success (defined as no need for reintubation after extubation)
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Istanbul, 34303, Turkey (Türkiye)
This is a prospective, observational, single-center study designed to investigate whether ventilator-derived physiological measurements can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of mechanical power (MP) in forecasting successful extubation.
Secondary objectives include the evaluation of additional respiratory parameters such as airway occlusion pressure (P0.1), negative inspiratory force (NIF), the rapid shallow breathing index (RSBI), and the mechanical power/negative inspiratory force ratio (MP/NIF). These parameters will be measured at the bedside within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.
All participants will be monitored for 48 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation after extubation during this period.
Data collection will include:
Respiratory measurements obtained from the ventilator: MP, P0.1, NIF, RSBI, and MP/NIF.
Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II scores, ventilator settings, and duration of mechanical ventilation.
Post-extubation follow-up: reintubation, non-invasive ventilation or high-flow oxygen use, SpO₂ values, blood gas analysis, and vital signs.
This study does not involve any interventions beyond standard ICU care. Ventilator-based respiratory assessments are routinely performed in ICU settings and pose no additional risk to participants.
The results may support the integration of load-drive-capacity assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Age ≥ 18 years (adult patient population)
Exclusion criteria
and
Non-invasive bedside evaluation of respiratory load, neural drive, and inspiratory muscle capacity using mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI).
Time frame: 48 hour
Mechanical Power (MP), a ventilator-derived estimate of the total mechanical energy transferred to the respiratory system per unit time, will be measured prior to planned extubation and evaluated in relation to extubation outcomes
Time frame: 48 hour
P0.1, an indicator of the patient's neural inspiratory drive that reflects the initial negative pressure generated at the start of a breath, will be measured prior to planned extubation and evaluated in relation to extubation outcomes
Time frame: 48 hour
NIF, a measure of maximal inspiratory muscle strength reflecting the patient's ability to generate negative pressure, will be obtained prior to planned extubation and evaluated in relation to extubation outcomes
Time frame: 48 hour
RSBI, an established index that incorporates respiratory rate and tidal volume to characterize rapid and shallow breathing, will be recorded prior to planned extubation and evaluated in relation to extubation outcomes
Time frame: 48 hour
The MP/NIF ratio, reflecting the relationship between ventilatory mechanical load and inspiratory muscle capacity, will be calculated prior to planned extubation and evaluated in relation to extubation outcomes
Anıl Berkay Balıtatlı
Other
Evaluation of Mechanical Power to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
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.
Published trials that share one or more normalized conditions with this study.
NCT07066748
Cardiovascular Abnormalities, Cardiovascular Diseases
Alexandria, Alexandria Governorate, Egypt
View Trial DetailsNCT07332403
Assesment of Diaphragmatic Function by Ultrasound to Predict Weaning Success in Mechanical Ventilated Intensive Care Unit Patients, Diaphragm Usg
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07518498
Hypnosis, Hypnosis During Weaning From Invasive Mechanical Ventilation
Nancy, France
View Trial DetailsNCT07324460
Airway Extubation, Extubation Failure
View Trial Details