Patients Undergoing General AnesthesiaGA-TARGETSNCT06047119
Respiratory and Hemodynamic Targets During General Anesthesia
A study testing Blood pressure, Positive end expiratory pressure and Tidal volume in people with Patients Undergoing General Anesthesia, run by Lars Wiuff Andersen at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing General Anesthesia
- What is being tested?
- Blood pressure, Positive end expiratory pressure and Tidal volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 6 sitesDenmark
- Study dates
- 9 Oct 2023to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Gødstrup Regional Hospital
Gødstrup
Horsens Regional Hospital
Horsens
Randers Regional Hospital
Randers
Viborg Regional Hospital
Viborg
About this study
Official title: Respiratory and Hemodynamic Targets During General Anesthesia - A Randomized Clinical Trial
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.
- Conditions
- Patients Undergoing General Anesthesia
- Being tested
- Blood pressure, Positive end expiratory pressure, Tidal volume, Fraction of inspired oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressureProcedure or surgery
Blood pressure targets during general anesthesia and 2 hours after
Positive end expiratory pressureProcedure or surgery
Positive end expiratory pressure during general anesthesia
Tidal volumeProcedure or surgery
Tidal volume during general anesthesia
Fraction of inspired oxygenProcedure or surgery
Fraction of inspired oxygen during general anesthesia and 2 hours after
| Study group | Role | What they receive |
|---|---|---|
| Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after | Experimental | Not described Receives: Procedure: Blood pressure |
| Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after | Experimental | Not described Receives: Procedure: Blood pressure |
| Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after | Experimental | Not described Receives: Procedure: Blood pressure |
| Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after | Experimental | Not described Receives: Procedure: Blood pressure |
| Positive end expiratory pressure 5 cm H20 during general anesthesia | Experimental | Not described Receives: Procedure: Positive end expiratory pressure |
| Positive end expiratory pressure 8 cm H20 during general anesthesia | Experimental | Not described Receives: Procedure: Positive end expiratory pressure |
| Positive end expiratory pressure 10 cm H20 during general anesthesia | Experimental | Not described Receives: Procedure: Positive end expiratory pressure |
| Tidal volume 5 ml/kg during general anesthesia | Experimental | Not described Receives: Procedure: Tidal volume |
| Tidal volume 8 ml/kg during general anesthesia | Experimental | Not described Receives: Procedure: Tidal volume |
| Tidal volume 10 ml/kg during general anesthesia | Experimental | Not described Receives: Procedure: Tidal volume |
| Fraction of inspired oxygen 30% during general anesthesia and 2 hours after | Experimental | Not described Receives: Procedure: Fraction of inspired oxygen |
| Fraction of inspired oxygen 80% during general anesthesia and 2 hours after | Experimental | Not described Receives: Procedure: Fraction of inspired oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 90 days
Secondary outcomes (30)
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.
Measured: 30 days
Proportion of patient with pneumonia
Based on the United States of America Centers for Disease Control and Prevention (CDC) definition of pneumonia
Measured: 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.
Measured: 30 days
Proportion of patient with acute kidney injury
Composite of post-operative renal complications using Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: 30 days
Creatinine
Measured in umol/L
Measured: 2 hours after the surgery
Creatinine
Measured in umol/L
Measured: 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.
Measured: 30 days
Troponin-I
Measured in ng/L
Measured: 2 hours after the surgery
Troponin-I
Measured in ng/L
Measured: 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.
Measured: 3 days
Alanine transaminase
Measured in U/L
Measured: 2 hours after the surgery
Alanine transaminase
Measured in U/L
Measured: 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.
Measured: 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
Measured: 7 days
Post-operative pain
Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse pain) documented
Measured: 2 hours after the surgery
Opioid administered
Total opioid administered using morphine equivalent units.
Measured: 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
Measured: 2 hours after the surgery
Antiemetic treatment
Administered antiemetic treatment (ondansetron, dexamethasone, cyclizine, droperidol, metoclopramide) within the first 24 hours after the operation.
Measured: 24 hours
Proportion of patients with surgical site infections
Based on the United States of America Centers for Disease Control and Prevention (CDC) definition.
Measured: 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.
Measured: 30 days
Proportion of patients with intensive care unit admission
Both planned and unplanned stays at the intensive care unit.
Measured: 30 days
Length of hospital stay
Reported in days.
Measured: 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.
Measured: Within 30 days
Proportion of patients with who die
Measured: 30 days
Proportion of patients with who die
Measured: 90 days
Health related quality of life
Based on the EQ-5D-5L questionnaire
Measured: 30 days
Health related quality of life
Based on the EQ-5D-5L questionnaire
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start9 Oct 2023
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Wiuff Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Wiuff Andersen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047119
- Sponsor's protocol ID
- 00005
- Acronym
- GA-TARGETS
- Status last verified
- Jul 2025
- First submitted
- 10 Aug 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35675085Bolther 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.
PubMed 35703253Bolther 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.
PubMed 35797424Holst 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.
PubMed 35924389Paelestik MB, Risager BH, Mortensen SO, Schjorring OL, Bisgaard J, Berthelsen KG, Balslov R, Bach L, Paelestik KB, Rossau JGR, Poulsen C, Solling C, Sorensen JT, Enevoldsen M, Petersen LDD, Zwisler ST, Brahe NM, Rasmussen AM, Guldberg IA, Joost MA, Nielsen HB, Espelund US, Brix LD, Petersen JAK, Eriksen CF, Kjaergaard AG, Dinesen PD, Abildgren ML, Vallentin MF, Jessen MK, Vistisen ST, Norholt CH, Baltsen CD, Andersen LK, Hansen FG, Frilund LW, Winther S, Granfelt A, Andersen LW. Blood Pressure Targets During General Anaesthesia in High-Risk Patients-A Randomised Clinical Feasibility Trial. Acta Anaesthesiol Scand. 2026 Sep;70(8):e70315. doi: 10.1111/aas.70315.
PubMed 42578528Paelestik MB, Risager BH, Mortensen SO, Schjorring OL, Bisgaard J, Berthelsen KG, Balslov R, Bach L, Paelestik KB, Rossau JGR, Poulsen C, Solling C, Sorensen JT, Enevoldsen M, Petersen LDD, Zwisler ST, Brahe NM, Rasmussen AM, Guldberg IA, Joost MA, Nielsen HB, Espelund US, Brix LD, Petersen JAK, Eriksen CF, Kjaergaard AG, Dinesen PD, Abildgren ML, Vallentin MF, Jessen MK, Vistisen ST, Norholt CH, Baltsen CD, Andersen LK, Hansen FG, Frilund LW, Winther S, Granfelt A, Andersen LW. Positive End-Expiratory Pressure, Tidal Volume, and Fraction of Inspired Oxygen During General Anaesthesia in High-Risk Patients-A Randomised Clinical Feasibility Trial. Acta Anaesthesiol Scand. 2026 Sep;70(8):e70309. doi: 10.1111/aas.70309.
PubMed 42508987
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory and Hemodynamic Targets During General Anesthesia - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06047119
- Acronym / sponsor ID
- GA-TARGETS / 00005
- Conditions
- Patients Undergoing General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Lars Wiuff AndersenUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after | Experimental | Procedure: Blood pressure |
| Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after | Experimental | Procedure: Blood pressure |
| Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after | Experimental | Procedure: Blood pressure |
| Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after | Experimental | Procedure: Blood pressure |
| Positive end expiratory pressure 5 cm H20 during general anesthesia | Experimental | Procedure: Positive end expiratory pressure |
| Positive end expiratory pressure 8 cm H20 during general anesthesia | Experimental | Procedure: Positive end expiratory pressure |
| Positive end expiratory pressure 10 cm H20 during general anesthesia | Experimental | Procedure: Positive end expiratory pressure |
| Tidal volume 5 ml/kg during general anesthesia | Experimental | Procedure: Tidal volume |
| Tidal volume 8 ml/kg during general anesthesia | Experimental | Procedure: Tidal volume |
| Tidal volume 10 ml/kg during general anesthesia | Experimental | Procedure: Tidal volume |
| Fraction of inspired oxygen 30% during general anesthesia and 2 hours after | Experimental | Procedure: Fraction of inspired oxygen |
| Fraction of inspired oxygen 80% during general anesthesia and 2 hours after | Experimental | Procedure: Fraction of inspired oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressureBlood pressure targets during general anesthesia and 2 hours after | Procedure or surgery | Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after, Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after, Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after, Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after |
| Positive end expiratory pressurePositive end expiratory pressure during general anesthesia | Procedure or surgery | Positive end expiratory pressure 10 cm H20 during general anesthesia, Positive end expiratory pressure 5 cm H20 during general anesthesia, Positive end expiratory pressure 8 cm H20 during general anesthesia |
| Tidal volumeTidal volume during general anesthesia | Procedure or surgery | Tidal volume 10 ml/kg during general anesthesia, Tidal volume 5 ml/kg during general anesthesia, Tidal volume 8 ml/kg during general anesthesia |
| Fraction of inspired oxygenFraction of inspired oxygen during general anesthesia and 2 hours after | Procedure or surgery | Fraction of inspired oxygen 30% during general anesthesia and 2 hours after, Fraction of inspired oxygen 80% during general anesthesia and 2 hours after |
Primary outcome
Feasibility: Proportion of eligible patients randomized
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 90 days
We aim to obtain data from more than 90% of patients still alive at 30- and 90-days follow-up.
30 secondary outcomes
Proportion of patients with pulmonary post-operative complications (composite)
Time frame: 30 days
Proportion of patient with pneumonia
Time frame: 30 days
Proportion of patient with pulmonary embolism
Time frame: 30 days
Proportion of patient with acute kidney injury
Time frame: 30 days
Creatinine
Time frame: 2 hours after the surgery
Creatinine
Time frame: The day after the surgery
Proportion of patient with major adverse cardiac events
Time frame: 30 days
Troponin-I
Time frame: 2 hours after the surgery
Troponin-I
Time frame: The day after the surgery
Proportion of patients with myocardial injury after non-cardiac surgery
Time frame: 3 days
Alanine transaminase
Time frame: 2 hours after the surgery
Alanine transaminase
Time frame: The day after the surgery
Proportion of patients with emergence delirium
Time frame: 2 hours after the surgery
Proportion of patients with post-operative delirium
Time frame: 7 days
Post-operative pain
Time frame: 2 hours after the surgery
Opioid administered
Time frame: 24 hours
Proportion of patients with post-operative nausea and vomiting
Time frame: 2 hours after the surgery
Antiemetic treatment
Time frame: 24 hours
Proportion of patients with surgical site infections
Time frame: 30 days
Clavien-Dindo grading of complications
Time frame: 30 days
Proportion of patients with intensive care unit admission
Time frame: 30 days
Length of hospital stay
Time frame: Up to 90 days
Days alive and out of the hospital
Time frame: Within 30 days
Proportion of patients with who die
Time frame: 30 days
Proportion of patients with who die
Time frame: 90 days
Health related quality of life
Time frame: 30 days
Health related quality of life
Time frame: 90 days
Proportion of patients with intraoperative complications
Time frame: During surgery
Quality of recovery
Time frame: 30 days
Quality of recovery
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 35675085Hoybye 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.
- Background: PubMed 35703253Bolther 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.
- Background: PubMed 35797424Bolther 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.
- Background: PubMed 35924389Holst 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.
- Derived from this study: PubMed 42578528Paelestik MB, Risager BH, Mortensen SO, Schjorring OL, Bisgaard J, Berthelsen KG, Balslov R, Bach L, Paelestik KB, Rossau JGR, Poulsen C, Solling C, Sorensen JT, Enevoldsen M, Petersen LDD, Zwisler ST, Brahe NM, Rasmussen AM, Guldberg IA, Joost MA, Nielsen HB, Espelund US, Brix LD, Petersen JAK, Eriksen CF, Kjaergaard AG, Dinesen PD, Abildgren ML, Vallentin MF, Jessen MK, Vistisen ST, Norholt CH, Baltsen CD, Andersen LK, Hansen FG, Frilund LW, Winther S, Granfelt A, Andersen LW. Blood Pressure Targets During General Anaesthesia in High-Risk Patients-A Randomised Clinical Feasibility Trial. Acta Anaesthesiol Scand. 2026 Sep;70(8):e70315. doi: 10.1111/aas.70315.
- Derived from this study: PubMed 42508987Paelestik MB, Risager BH, Mortensen SO, Schjorring OL, Bisgaard J, Berthelsen KG, Balslov R, Bach L, Paelestik KB, Rossau JGR, Poulsen C, Solling C, Sorensen JT, Enevoldsen M, Petersen LDD, Zwisler ST, Brahe NM, Rasmussen AM, Guldberg IA, Joost MA, Nielsen HB, Espelund US, Brix LD, Petersen JAK, Eriksen CF, Kjaergaard AG, Dinesen PD, Abildgren ML, Vallentin MF, Jessen MK, Vistisen ST, Norholt CH, Baltsen CD, Andersen LK, Hansen FG, Frilund LW, Winther S, Granfelt A, Andersen LW. Positive End-Expiratory Pressure, Tidal Volume, and Fraction of Inspired Oxygen During General Anaesthesia in High-Risk Patients-A Randomised Clinical Feasibility Trial. Acta Anaesthesiol Scand. 2026 Sep;70(8):e70309. doi: 10.1111/aas.70309.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure, Positive end expiratory pressure and Tidal volume in people with Patients Undergoing General Anesthesia, run by Lars Wiuff Andersen at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Proportion of eligible patients randomized (time frame: Up to 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047119, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.