No registrations found.
ID
Source
Brief title
Health condition
Pulmonary surgery, intensive care, effective intensive care use, adverse events
Sponsors and support
Intervention
Outcome measures
Primary outcome
-invasive mechanical ventilation (initiated on the ICU or continued from the operating theatre for at least 3 hours)
-non-invasive mechanical ventilation (use of continuous positive airway pressure)
-reintubation
-use of high-flow nasal oxygen therapy Optiflow)
-pneumothorax requiring (new) chest tube insertion or repositioning chest tube
-need for bronchoscopy
-bleeding requiring intervention (requiring surgery or transfusion of blood (clotting) products)
-reoperation
-supraventricular arrhythmia (new-onset atrial fibrillation or atrial flutter) with hemodynamic impairment
-congestive heart failure (pleural effusion or pulmonary edema requiring diuretic therapy)
-myocardial infarction (elevated hs-cTn in combination with clinical symptoms or electrocardiography changes)
-hemodynamic instability requiring the use of vasopressors or inotropes
Secondary outcome
-pneumonia (purulent sputum, positive sputum or blood culture and clinical symptoms such as cough, fever or consolidation on chest radiograph)
-pulmonary empyema (pleural effusion and the presence of pus on pleural aspiration, microorganism on pleural fluid culture or positive pleural fluid Gram stain)
-sepsis (qSOFA score ≥2 in response to an infection)
-wound infection (purulent drainage from superficial incision or deliberate opening of superficial incision by surgeon and pain, tenderness, swelling or redness)
-urinary tract infection (urinary tract symptoms or fever and urine culture with no more than 2 species of organisms identified with at least one of which is a bacterium of ≥105 CFU/ml)
-acute kidney injury (increase in serum creatinine by ≥ 26 µmol/l, a percentage increase in serum creatinine of more than or equal to 50% or oliguria of less than 0.5 ml/kg per hour for more than six hours within 48 hours)
-respiratory insufficiency (hypoxia or hypercapnia leading to ICU (re)admission)
-reoperation
-supraventricular arrhythmia (new-onset atrial fibrillation or atrial flutter)
-congestive heart failure (pleural effusion or pulmonary edema requiring diuretic therapy)
-acute respiratory distress syndrome (defined as diffuse inflammatory lung injury (onset over 1 week or less), bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph, PF ratio <300mmHg with a minimum of 5 cmH20 PEEP (or CPAP) must not be fully explained by cardiac failure or fluid overload
-pulmonary embolus (filling defect ≥ 75% in a pulmonary artery with corresponding normal ventilation
-stroke (clinical diagnosis of acute transient ischemic attack (TIA) or cerebrovascular accident (CVA))
-myocardial infarction (elevated hs-cTn in combination with clinical symptoms or electrocardiography changes)
-mortality
Background summary
Rationale: It is unclear whether admission to an Intensive Care Unit (ICU) to prevent adverse events after pulmonary surgery is necessary.
Objective: To identify which patients may benefit from admission to the ICU after pulmonary surgery and to develop a clinical prediction model for future effective ICU use.
Study design: Multicenter retrospective cohort study.
Study population: Patients that underwent elective pulmonary surgery (pneumonectomy, (bi)(sleeve)lobectomy, segmentectomy), with a postoperative admission to the ICU.
Intervention: Not applicable.
Main study parameters/endpoints: Factors that pose an immediate threat to life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Not applicable.
Study objective
Routine admission to the ICU after pulmonary surgery may not necessarily be required for each patient. The aim of this study is to identify which patients may benefit from admission to the ICU after pulmonary surgery and to develop a clinical prediction model for future effective ICU use.
Study design
primary endpoints are scored before 08.00 on the first postoperative morning and
secondary endpoints are scored within 30 days of surgery
Intervention
not applicable
Inclusion criteria
Patients that underwent elective pulmonary surgery (pneumonectomy, (bi)(sleeve)lobectomy, segmentectomy), with a postoperative admission to the ICU are included.
Exclusion criteria
Intraoperative death.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7013 |
| NTR-old | NTR7211 |
| CCMO | NL2018.24.1.1 |