Clinical trial NCT06047119: Respiratory and Hemodynamic Targets During General Anesthesia
Official title: Respiratory and Hemodynamic Targets During General Anesthesia - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patients Undergoing General Anesthesia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Proportion of eligible patients randomized
timeFrame: Up to 90 days
measure: Feasibility: Proportion of patient with adherence to the assigned interventions
timeFrame: During surgery
measure: Feasibility: Proportion of patients with separation of mean arterial pressure
timeFrame: During surgery
measure: Feasibility: Proportion of patients lost to follow-up
timeFrame: Up to 90 days
Secondary outcomes:
measure: Proportion of patients with pulmonary post-operative complications (composite)
timeFrame: 30 days
measure: Proportion of patient with pneumonia
timeFrame: 30 days
measure: Proportion of patient with pulmonary embolism
timeFrame: 30 days
measure: Proportion of patient with acute kidney injury
timeFrame: 30 days
measure: Creatinine
timeFrame: 2 hours after the surgery
measure: Creatinine
timeFrame: The day after the surgery
measure: Proportion of patient with major adverse cardiac events
timeFrame: 30 days
measure: Troponin-I
timeFrame: 2 hours after the surgery
measure: Troponin-I
timeFrame: The day after the surgery
measure: Proportion of patients with myocardial injury after non-cardiac surgery
timeFrame: 3 days
measure: Alanine transaminase
timeFrame: 2 hours after the surgery
measure: Alanine transaminase
timeFrame: The day after the surgery
measure: Proportion of patients with emergence delirium
timeFrame: 2 hours after the surgery
measure: Proportion of patients with post-operative delirium
timeFrame: 7 days
measure: Post-operative pain
timeFrame: 2 hours after the surgery
measure: Opioid administered
timeFrame: 24 hours
measure: Proportion of patients with post-operative nausea and vomiting
timeFrame: 2 hours after the surgery
measure: Antiemetic treatment
timeFrame: 24 hours
measure: Proportion of patients with surgical site infections
timeFrame: 30 days
measure: Clavien-Dindo grading of complications
timeFrame: 30 days
measure: Proportion of patients with intensive care unit admission
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: Up to 90 days
measure: Days alive and out of the hospital
timeFrame: Within 30 days
measure: Proportion of patients with who die
timeFrame: 30 days
measure: Proportion of patients with who die
timeFrame: 90 days
measure: Health related quality of life
timeFrame: 30 days
measure: Health related quality of life
timeFrame: 90 days
measure: Proportion of patients with intraoperative complications
timeFrame: During surgery
measure: Quality of recovery
timeFrame: 30 days
measure: Quality of recovery
timeFrame: 90 days
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Gødstrup
country: Denmark
facility: Gødstrup Regional Hospital
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.