Respiratory and Hemodynamic Targets During General Anesthesia
GA-TARGETS
1 other identifier
interventional
485
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2025
CompletedAugust 5, 2025
July 1, 2025
1.5 years
August 10, 2023
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (30)
Proportion of patients with pulmonary post-operative complications (composite)
30 days
Proportion of patient with pneumonia
30 days
Proportion of patient with pulmonary embolism
30 days
Proportion of patient with acute kidney injury
30 days
Creatinine
2 hours after the surgery
- +25 more secondary outcomes
Study Arms (12)
Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after
EXPERIMENTALMean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after
EXPERIMENTALMean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after
EXPERIMENTALSystolic blood pressure above 90% of baseline during general anesthesia and 2 hours after
EXPERIMENTALPositive end expiratory pressure 5 cm H20 during general anesthesia
EXPERIMENTALPositive end expiratory pressure 8 cm H20 during general anesthesia
EXPERIMENTALPositive end expiratory pressure 10 cm H20 during general anesthesia
EXPERIMENTALTidal volume 5 ml/kg during general anesthesia
EXPERIMENTALTidal volume 8 ml/kg during general anesthesia
EXPERIMENTALTidal volume 10 ml/kg during general anesthesia
EXPERIMENTALFraction of inspired oxygen 30% during general anesthesia and 2 hours after
EXPERIMENTALFraction of inspired oxygen 80% during general anesthesia and 2 hours after
EXPERIMENTALInterventions
Blood pressure targets during general anesthesia and 2 hours after
Positive end expiratory pressure during general anesthesia
Tidal volume during general anesthesia
Fraction of inspired oxygen during general anesthesia and 2 hours after
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Gødstrup Regional Hospital
Gødstrup, Denmark
Horsens Regional Hospital
Horsens, Denmark
Randers Regional Hospital
Randers, Denmark
Viborg Regional Hospital
Viborg, Denmark
Related Publications (4)
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.
PMID: 35675085BACKGROUNDBolther 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.
PMID: 35703253BACKGROUNDBolther 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.
PMID: 35797424BACKGROUNDHolst 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.
PMID: 35924389BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 10, 2023
First Posted
September 21, 2023
Study Start
October 9, 2023
Primary Completion
April 24, 2025
Study Completion
April 24, 2025
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Access Criteria
- 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.
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.