Respiratory and Hemodynamic Targets During General Anesthesia

Not Applicable

Completed

• Conditions: Patients Undergoing General Anesthesia

• Registration Number: NCT06047119
• Lead Sponsor: Lars Wiuff Andersen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-10-09
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Feasibility: Proportion of eligible patients randomized	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	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	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	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 Outcome Measures

Name	Time	Method
Proportion of patients with pulmonary post-operative complications (composite)	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.
Proportion of patient with pneumonia	30 days	Based on the United States of America Centers for Disease Control and Prevention (CDC) definition of pneumonia
Proportion of patient with pulmonary embolism	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.
Proportion of patient with major adverse cardiac events	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.
Troponin-I	The day after the surgery	Measured in ng/L
Proportion of patients with myocardial injury after non-cardiac surgery	3 days	Post-operative troponin-I above the 99% percentile for the respective assay.
Proportion of patients with emergence delirium	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.
Opioid administered	24 hours	Total opioid administered using morphine equivalent units.
Proportion of patients with surgical site infections	30 days	Based on the United States of America Centers for Disease Control and Prevention (CDC) definition.
Proportion of patients with who die	90 days
Health related quality of life	90 days	Based on the EQ-5D-5L questionnaire
Proportion of patients with post-operative delirium	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
Post-operative pain	2 hours after the surgery	Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse pain) documented
Quality of recovery	90 days	Based on the quality of recovery-15 (QoR-15) score. The score ranges from 0-150 with higher scores indicating better recovery.
Proportion of patients with post-operative nausea and vomiting	2 hours after the surgery	Highest numeric rating scale (NRS) score (from 0 to 10 with higher scores indicating worse nausea and vomiting) documented
Antiemetic treatment	24 hours	Administered antiemetic treatment (ondansetron, dexamethasone, cyclizine, droperidol, metoclopramide) within the first 24 hours after the operation.
Length of hospital stay	Up to 90 days	Reported in days.
Days alive and out of the hospital	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.
Proportion of patients with intraoperative complications	During surgery	Specific complications occurring during the surgery: Bleeding, need of blood product transfusions, arrhythmia, pneumothorax, cardiac arrest, mortality.
Clavien-Dindo grading of complications	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.
Proportion of patients with intensive care unit admission	30 days	Both planned and unplanned stays at the intensive care unit.
Proportion of patient with acute kidney injury	30 days	Composite of post-operative renal complications using Kidney Disease Improving Global Outcomes (KDIGO) criteria
Creatinine	The day after the surgery	Measured in umol/L
Alanine transaminase	The day after the surgery	Measured in U/L

Trial Locations

Locations (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