Respiratory and Hemodynamic Targets During General Anesthesia
- Conditions
- Patients Undergoing General Anesthesia
- Interventions
- Procedure: Fraction of inspired oxygenProcedure: Positive end expiratory pressureProcedure: Blood pressureProcedure: Tidal volume
- Registration Number
- NCT06047119
- Lead Sponsor
- Lars Wiuff Andersen
- Brief Summary
This trial is an investigator-initiated, multicenter, randomized, factorial, single-blind trial of multiple hemodynamic and respiratory targets during general anesthesia. These targets include blood pressure, positive end expiratory pressure, tidal volume, and fraction of inspired oxygen. Patients will be randomized to different targets using a factorial design, i.e., each patient is simultaneously randomized to four interventions. There will be five enrolling sites in the Central Denmark Region. 480 high-risk patients will be enrolled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 480
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) classification 3 to 5
- Planned endotracheal intubation with positive pressure ventilation
- Expected operating time ≥ 90 minutes
- Certain types of surgery
- Inability to obtain consent (e.g., patient is unconscious, hyperacute surgery)
- Known or suspected pregnancy
- Out-patient/same-day surgery
- Intubated prior to surgery
- Clinical judgement by the anesthesiologist that any of the interventions could be potentially harmful to the patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Fraction of inspired oxygen 80% during general anesthesia and 2 hours after Fraction of inspired oxygen - Positive end expiratory pressure 10 cm H20 during general anesthesia Positive end expiratory pressure - Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after Blood pressure - Tidal volume 10 ml/kg during general anesthesia Tidal volume - Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after Blood pressure - Positive end expiratory pressure 5 cm H20 during general anesthesia Positive end expiratory pressure - Tidal volume 5 ml/kg during general anesthesia Tidal volume - Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after Blood pressure - Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after Blood pressure - Positive end expiratory pressure 8 cm H20 during general anesthesia Positive end expiratory pressure - Tidal volume 8 ml/kg during general anesthesia Tidal volume - Fraction of inspired oxygen 30% during general anesthesia and 2 hours after Fraction of inspired oxygen -
- Primary Outcome Measures
Name Time Method Feasibility: Proportion of eligible patients randomized Up to 90 days Eligible patients will be defined as those meeting all inclusion criteria and none of the exclusion criteria 1 to 4.
Feasibility: Proportion of patient with adherence to the assigned interventions During surgery Adherence will be defined as follows:
The allocated positive end expiratory pressure (± 1 cm H2O), tidal volume (± 1 ml/kg), and FiO2 (± 5%) is used in a minimum of 90% of the randomized patients for the duration of the surgery.
Vasopressors/inotropes are only initiated and continued if the blood pressure declines below the allocated target in at least 60% of the patients and at least 60% of time during general anesthesia, i.e., 60% of the registered blood pressures should be within +/- 10 mmHg of the target when vasopressor/inotropes are administered.Feasibility: Proportion of patients with separation of mean arterial pressure During surgery We aim to achieve at least 5 mmHg separation in mean/median mean arterial pressure for the three blood pressure groups targeting mean arterial pressure.
Feasibility: Proportion of patients lost to follow-up Up to 90 days We aim to obtain data from more than 90% of patients still alive at 30- and 90-days follow-up.
- Secondary Outcome Measures
Name Time Method Proportion of patient with acute kidney injury 30 days Composite of post-operative renal complications using Kidney Disease Improving Global Outcomes (KDIGO) criteria
Creatinine The day after the surgery Measured in umol/L
Proportion of patients with pulmonary post-operative complications (composite) 30 days A composite of the following based on European Perioperative Clinical Outcome definitions: Respirator infection, respirator failure, pleural effusion, atelectasis, pneumothorax, bronchospasms, and aspiration pneumonitis.
Proportion of patient with pneumonia 30 days Based on the United States of America Centers for Disease Control and Prevention (CDC) definition of pneumonia
Proportion of patient with pulmonary embolism 30 days Presence of pulmonary embolus on computerized tomography (CT) or magnetic resonance (MR) imaging, or a high probability of pulmonary embolus based on ventilation perfusion scan.
Proportion of patient with major adverse cardiac events 30 days A composite of the following based on European Perioperative Clinical Outcome definitions: Non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, and angina.
Troponin-I The day after the surgery Measured in ng/L
Proportion of patients with myocardial injury after non-cardiac surgery 3 days Post-operative troponin-I above the 99% percentile for the respective assay.
Alanine transaminase The day after the surgery Measured in U/L
Proportion of patients with emergence delirium 2 hours after the surgery Based on the nursing delirium screening scale to evaluate emergence delirium 90-120 minutes after admission to the post-aesthesia care unit.
Opioid administered 24 hours Total opioid administered using morphine equivalent units.
Proportion of patients with surgical site infections 30 days Based on the United States of America Centers for Disease Control and Prevention (CDC) definition.
Proportion of patients with who die 90 days Health related quality of life 90 days Based on the EQ-5D-5L questionnaire
Proportion of patients with post-operative delirium 7 days We will categorize delirium as delirium if this is either stated in the medical journal or retrospectively categorized as delirium if it meets pre-defined criteria based on the diagnostic and statistical manual of mental disorders, fifth edition from the American psychiatric association
Post-operative pain 2 hours after the surgery Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse pain) documented
Quality of recovery 90 days Based on the quality of recovery-15 (QoR-15) score. The score ranges from 0-150 with higher scores indicating better recovery.
Proportion of patients with post-operative nausea and vomiting 2 hours after the surgery Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse nausea and vomiting) documented
Antiemetic treatment 24 hours Administered antiemetic treatment (ondansetron, dexamethasone, cyclizine, droperidol, metoclopramide) within the first 24 hours after the operation.
Length of hospital stay Up to 90 days Reported in days.
Days alive and out of the hospital Within 30 days Reported in days. Patients that die during the 30 days, will receive a value of 0. All admissions at acute care hospitals in Denmark will be included in this outcome.
Proportion of patients with intraoperative complications During surgery Specific complications occurring during the surgery: Bleeding, need of blood product transfusions, arrhythmia, pneumothorax, cardiac arrest, mortality.
Clavien-Dindo grading of complications 30 days In addition to reporting the individual post-operative complications, we will use the validated Clavien-Dindo classification to grade post-operative complications by the interventions needed.
Proportion of patients with intensive care unit admission 30 days Both planned and unplanned stays at the intensive care unit.
Trial Locations
- Locations (6)
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Horsens Regional Hospital
🇩🇰Horsens, Denmark
Randers Regional Hospital
🇩🇰Randers, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Gødstrup Regional Hospital
🇩🇰Gødstrup, Denmark