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Completed

NCT Number: NCT06047119

Respiratory and Hemodynamic Targets During General Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blood pressure

Procedure

Blood pressure targets during general anesthesia and 2 hours after

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Proportion of patients with pulmonary post-operative complications (composite)

    Time frame: 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.

  2. Proportion of patient with pneumonia

    Time frame: 30 days

    Based on the United States of America Centers for Disease Control and Prevention (CDC) definition of pneumonia

  3. Proportion of patient with pulmonary embolism

    Time frame: 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.

  4. Proportion of patient with acute kidney injury

    Time frame: 30 days

    Composite of post-operative renal complications using Kidney Disease Improving Global Outcomes (KDIGO) criteria

  5. Creatinine

    Time frame: 2 hours after the surgery

    Measured in umol/L

  6. Creatinine

    Time frame: The day after the surgery

    Measured in umol/L

  7. Proportion of patient with major adverse cardiac events

    Time frame: 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.

  8. Troponin-I

    Time frame: 2 hours after the surgery

    Measured in ng/L

  9. Troponin-I

    Time frame: The day after the surgery

    Measured in ng/L

  10. Proportion of patients with myocardial injury after non-cardiac surgery

    Time frame: 3 days

    Post-operative troponin-I above the 99% percentile for the respective assay.

  11. Alanine transaminase

    Time frame: 2 hours after the surgery

    Measured in U/L

  12. Alanine transaminase

    Time frame: The day after the surgery

    Measured in U/L

  13. Proportion of patients with emergence delirium

    Time frame: 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.

  14. Proportion of patients with post-operative delirium

    Time frame: 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

  15. Post-operative pain

    Time frame: 2 hours after the surgery

    Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse pain) documented

  16. Opioid administered

    Time frame: 24 hours

    Total opioid administered using morphine equivalent units.

  17. Proportion of patients with post-operative nausea and vomiting

    Time frame: 2 hours after the surgery

    Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse nausea and vomiting) documented

  18. Antiemetic treatment

    Time frame: 24 hours

    Administered antiemetic treatment (ondansetron, dexamethasone, cyclizine, droperidol, metoclopramide) within the first 24 hours after the operation.

  19. Proportion of patients with surgical site infections

    Time frame: 30 days

    Based on the United States of America Centers for Disease Control and Prevention (CDC) definition.

  20. Clavien-Dindo grading of complications

    Time frame: 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.

  21. Proportion of patients with intensive care unit admission

    Time frame: 30 days

    Both planned and unplanned stays at the intensive care unit.

  22. Length of hospital stay

    Time frame: Up to 90 days

    Reported in days.

  23. Days alive and out of the hospital

    Time frame: 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.

  24. Proportion of patients with who die

    Time frame: 30 days

  25. Proportion of patients with who die

    Time frame: 90 days

  26. Health related quality of life

    Time frame: 30 days

    Based on the EQ-5D-5L questionnaire

  27. Health related quality of life

    Time frame: 90 days

    Based on the EQ-5D-5L questionnaire

  28. Proportion of patients with intraoperative complications

    Time frame: During surgery

    Specific complications occurring during the surgery: Bleeding, need of blood product transfusions, arrhythmia, pneumothorax, cardiac arrest, mortality.

  29. Quality of recovery

    Time frame: 30 days

    Based on the quality of recovery-15 (QoR-15) score. The score ranges from 0-150 with higher scores indicating better recovery.

  30. Quality of recovery

    Time frame: 90 days

    Based on the quality of recovery-15 (QoR-15) score. The score ranges from 0-150 with higher scores indicating better recovery.

Sponsors and collaborators

Lead sponsor

Lars Wiuff Andersen

Other

Registry information

Official study title

Respiratory and Hemodynamic Targets During General Anesthesia - A Randomized Clinical Trial

Acronym: GA-TARGETS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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