Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after | Experimental |
| |
| Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after | Experimental |
| |
| Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after | Experimental |
| |
| Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after | Experimental |
| |
| Positive end expiratory pressure 5 cm H20 during general anesthesia | Experimental |
| |
| Positive end expiratory pressure 8 cm H20 during general anesthesia | Experimental |
| |
| Positive end expiratory pressure 10 cm H20 during general anesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure | Procedure | Blood pressure targets during general anesthesia and 2 hours after |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Proportion of eligible patients randomized | Eligible patients will be defined as those meeting all inclusion criteria and none of the exclusion criteria 1 to 4. | Up to 90 days |
| Feasibility: Proportion of patient with adherence to the assigned interventions | 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. | During surgery |
| Feasibility: Proportion of patients with separation of mean arterial pressure | 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. | During surgery |
| Feasibility: Proportion of patients lost to follow-up | We aim to obtain data from more than 90% of patients still alive at 30- and 90-days follow-up. | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with pulmonary post-operative complications (composite) | A composite of the following based on European Perioperative Clinical Outcome definitions: Respirator infection, respirator failure, pleural effusion, atelectasis, pneumothorax, bronchospasms, and aspiration pneumonitis. | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35675085 | Background | Hoybye M, Lind PC, Holmberg MJ, Bolther M, Jessen MK, Vallentin MF, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Henriksen J, Karlsson M, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Fraction of inspired oxygen during general anesthesia for non-cardiac surgery: Systematic review and meta-analysis. Acta Anaesthesiol Scand. 2022 Sep;66(8):923-933. doi: 10.1111/aas.14102. Epub 2022 Jun 23. | |
| 35703253 |
Not provided
Not provided
Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law.
All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.
Not provided
Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator. Authorship of publications emerging from the shared data will follow standard authorship guidelines from the International Committee of Medical Journal Editors and might or might not include authors from the steering committee depending on the nature of their involvement.
Not provided
Not provided
| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D011175 | Positive-Pressure Respiration |
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
|
| Tidal volume 5 ml/kg during general anesthesia | Experimental |
|
| Tidal volume 8 ml/kg during general anesthesia | Experimental |
|
| Tidal volume 10 ml/kg during general anesthesia | Experimental |
|
| Fraction of inspired oxygen 30% during general anesthesia and 2 hours after | Experimental |
|
| Fraction of inspired oxygen 80% during general anesthesia and 2 hours after | Experimental |
|
| Positive end expiratory pressure | Procedure | Positive end expiratory pressure during general anesthesia |
|
| Tidal volume | Procedure | Tidal volume during general anesthesia |
|
| Fraction of inspired oxygen | Procedure | Fraction of inspired oxygen during general anesthesia and 2 hours after |
|
| Proportion of patient with pneumonia |
Based on the United States of America Centers for Disease Control and Prevention (CDC) definition of pneumonia |
| 30 days |
| Proportion of patient with pulmonary embolism | 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. | 30 days |
| Proportion of patient with acute kidney injury | Composite of post-operative renal complications using Kidney Disease Improving Global Outcomes (KDIGO) criteria | 30 days |
| Creatinine | Measured in umol/L | 2 hours after the surgery |
| Creatinine | Measured in umol/L | The day after the surgery |
| Proportion of patient with major adverse cardiac events | 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. | 30 days |
| Troponin-I | Measured in ng/L | 2 hours after the surgery |
| Troponin-I | Measured in ng/L | The day after the surgery |
| Proportion of patients with myocardial injury after non-cardiac surgery | Post-operative troponin-I above the 99% percentile for the respective assay. | 3 days |
| Alanine transaminase | Measured in U/L | 2 hours after the surgery |
| Alanine transaminase | Measured in U/L | The day after the surgery |
| Proportion of patients with emergence delirium | Based on the nursing delirium screening scale to evaluate emergence delirium 90-120 minutes after admission to the post-aesthesia care unit. | 2 hours after the surgery |
| Proportion of patients with post-operative delirium | 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 | 7 days |
| Post-operative pain | Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse pain) documented | 2 hours after the surgery |
| Opioid administered | Total opioid administered using morphine equivalent units. | 24 hours |
| Proportion of patients with post-operative nausea and vomiting | Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse nausea and vomiting) documented | 2 hours after the surgery |
| Antiemetic treatment | Administered antiemetic treatment (ondansetron, dexamethasone, cyclizine, droperidol, metoclopramide) within the first 24 hours after the operation. | 24 hours |
| Proportion of patients with surgical site infections | Based on the United States of America Centers for Disease Control and Prevention (CDC) definition. | 30 days |
| Clavien-Dindo grading of complications | 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. | 30 days |
| Proportion of patients with intensive care unit admission | Both planned and unplanned stays at the intensive care unit. | 30 days |
| Length of hospital stay | Reported in days. | Up to 90 days |
| Days alive and out of the hospital | 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. | Within 30 days |
| Proportion of patients with who die | 30 days |
| Proportion of patients with who die | 90 days |
| Health related quality of life | Based on the EQ-5D-5L questionnaire | 30 days |
| Health related quality of life | Based on the EQ-5D-5L questionnaire | 90 days |
| Proportion of patients with intraoperative complications | Specific complications occurring during the surgery: Bleeding, need of blood product transfusions, arrhythmia, pneumothorax, cardiac arrest, mortality. | During surgery |
| Quality of recovery | Based on the quality of recovery-15 (QoR-15) score. The score ranges from 0-150 with higher scores indicating better recovery. | 30 days |
| Quality of recovery | Based on the quality of recovery-15 (QoR-15) score. The score ranges from 0-150 with higher scores indicating better recovery. | 90 days |
| Aarhus |
| Denmark |
| Gødstrup Regional Hospital | Gødstrup | Denmark |
| Horsens Regional Hospital | Horsens | Denmark |
| Randers Regional Hospital | Randers | Denmark |
| Viborg Regional Hospital | Viborg | Denmark |
| Background |
| Bolther M, Henriksen J, Holmberg MJ, Jessen MK, Vallentin MF, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Caroe Lind P, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Karlsson M, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Ventilation Strategies During General Anesthesia for Noncardiac Surgery: A Systematic Review and Meta-Analysis. Anesth Analg. 2022 Nov 1;135(5):971-985. doi: 10.1213/ANE.0000000000006106. Epub 2022 Oct 21. |
| 35797424 | Background | Bolther M, Henriksen J, Holmberg MJ, Granfeldt A, Andersen LW. Blood pressure targets during general anaesthesia for noncardiac surgery: A systematic review of clinical trials. Eur J Anaesthesiol. 2022 Nov 1;39(11):903-905. doi: 10.1097/EJA.0000000000001703. Epub 2022 Jul 5. No abstract available. |
| 35924389 | Background | Holst JM, Klitholm MP, Henriksen J, Vallentin MF, Jessen MK, Bolther M, Holmberg MJ, Hoybye M, Lind PC, Granfeldt A, Andersen LW. Intraoperative respiratory and hemodynamic strategies for reducing nausea, vomiting, and pain after surgery: Systematic review and meta-analysis. Acta Anaesthesiol Scand. 2022 Oct;66(9):1051-1060. doi: 10.1111/aas.14127. Epub 2022 Aug 22. |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D012143 | Respiratory Physiological Phenomena |