Trial · NCT07889609
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Association Between Intra-Abdominal Pressure and Static Respiratory System Compliance | From ICU admission through 48 hours after ICU admission | The longitudinal association between intra-abdominal pressure (IAP, mmHg) and static respiratory system compliance (mL/cmH2O) will be evaluated using repeated simultaneous measurements obtained within the first hour after postoperative ICU admission and at 6, 12, 18, 24, 36, and 48 hours. Static respiratory system compliance will be calculated as tidal volume divided by the difference between plateau pressure and total positive end-expiratory pressure (PEEP). Linear mixed-effects models will be used to assess within-patient and between-patient associations between IAP and static respiratory system compliance, accounting for repeated measurements. |
| Primary | Time to Successful Liberation From Invasive Mechanical Ventilation | From ICU admission through day 28 | Time from postoperative ICU admission to successful liberation from invasive mechanical ventilation will be assessed within 28 days. Successful liberation is defined as extubation followed by survival without reintubation for seven consecutive days. The association between IAP trajectories during the first 48 hours and time to successful ventilator liberation will be evaluated using competing-risk regression, with death before successful liberation treated as a competing event. |
| Secondary | Association Between Intra-Abdominal Pressure and Driving Pressure | From ICU admission through 48 hours after ICU admission | The longitudinal association between intra-abdominal pressure (mmHg) and respiratory system driving pressure (cmH2O) will be evaluated using simultaneous repeated measurements. Driving pressure will be calculated as plateau pressure minus total PEEP. Linear mixed-effects models will account for repeated measurements within individual patients. |
| Secondary | Invasive Mechanical Ventilation Requirement on Day 7 | Day 7 after ICU admission | The proportion of participants who remain dependent on invasive mechanical ventilation on day 7 after postoperative ICU admission will be assessed. The association between early IAP measurements and continued ventilation will be investigated. |
| Secondary | Early Extubation Failure | Within 48 hours after extubation, during the 28-day follow-up | The proportion of extubated participants requiring reintubation within 48 hours after extubation will be recorded. |
| Secondary | Ventilator-Free Days Through Day 28 | From ICU admission through day 28 | The number of days alive and free from invasive mechanical ventilation during the first 28 days after postoperative ICU admission will be calculated. |
| Secondary | Total Duration of Invasive Mechanical Ventilation | From ICU admission through day 28 | The cumulative duration of invasive mechanical ventilation will be recorded in hours from postoperative ICU admission, including subsequent invasive ventilation episodes during follow-up. |
| Secondary | Spontaneous Breathing Trial Failure | From ICU admission through day 28 | The proportion of participants experiencing failure of a spontaneous breathing trial (SBT) will be recorded. SBT failure will be determined according to predefined clinical criteria, including respiratory distress, oxygen desaturation, hemodynamic instability, or other signs of intolerance. |
| Secondary | Tracheostomy Requirement | From ICU admission through day 28 | The proportion of participants requiring tracheostomy during postoperative intensive care follow-up will be recorded. |
| Secondary | ICU Mortality Within 28 Days | From ICU admission through day 28 | The proportion of participants who die during their postoperative intensive care unit stay will be recorded. |
| Secondary | All-Cause Mortality at Day 28 | From ICU admission through day 28 | The proportion of participants who die from any cause within 28 days after postoperative ICU admission will be recorded. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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