GA-TARGETS: Respiratory and Hemodynamic Targets During General Anesthesia

Sponsor

Lars Wiuff Andersen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06047119

Collaborator

(none)

480

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing General Anesthesia	Procedure: Blood pressure Procedure: Positive end expiratory pressure Procedure: Tidal volume Procedure: Fraction of inspired oxygen	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after	Procedure: Blood pressure Blood pressure targets during general anesthesia and 2 hours after
Experimental: Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after	Procedure: Blood pressure Blood pressure targets during general anesthesia and 2 hours after
Experimental: Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after	Procedure: Blood pressure Blood pressure targets during general anesthesia and 2 hours after
Experimental: Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after	Procedure: Blood pressure Blood pressure targets during general anesthesia and 2 hours after
Experimental: Positive end expiratory pressure 5 cm H20 during general anesthesia	Procedure: Positive end expiratory pressure Positive end expiratory pressure during general anesthesia
Experimental: Positive end expiratory pressure 8 cm H20 during general anesthesia	Procedure: Positive end expiratory pressure Positive end expiratory pressure during general anesthesia
Experimental: Positive end expiratory pressure 10 cm H20 during general anesthesia	Procedure: Positive end expiratory pressure Positive end expiratory pressure during general anesthesia
Experimental: Tidal volume 5 ml/kg during general anesthesia	Procedure: Tidal volume Tidal volume during general anesthesia
Experimental: Tidal volume 8 ml/kg during general anesthesia	Procedure: Tidal volume Tidal volume during general anesthesia
Experimental: Tidal volume 10 ml/kg during general anesthesia	Procedure: Tidal volume Tidal volume during general anesthesia
Experimental: Fraction of inspired oxygen 30% during general anesthesia and 2 hours after	Procedure: Fraction of inspired oxygen Fraction of inspired oxygen during general anesthesia and 2 hours after
Experimental: Fraction of inspired oxygen 80% during general anesthesia and 2 hours after	Procedure: Fraction of inspired oxygen Fraction of inspired oxygen during general anesthesia and 2 hours after

Outcome Measures

Primary Outcome Measures

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

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 acute kidney injury [30 days]
Composite of post-operative renal complications using Kidney Disease Improving Global Outcomes (KDIGO) criteria
Creatinine [2 hours after the surgery]
Measured in umol/L
Creatinine [The day after the surgery]
Measured in umol/L
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 [2 hours after the surgery]
Measured in ng/L
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.
Alanine transaminase [2 hours after the surgery]
Measured in U/L
Alanine transaminase [The day after the surgery]
Measured in U/L
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.
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
Opioid administered [24 hours]
Total opioid administered using morphine equivalent units.
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.
Proportion of patients with surgical site infections [30 days]
Based on the United States of America Centers for Disease Control and Prevention (CDC) definition.
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.
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 who die [30 days]
Proportion of patients with who die [90 days]
Health related quality of life [30 days]
Based on the EQ-5D-5L questionnaire
Health related quality of life [90 days]
Based on the EQ-5D-5L questionnaire
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Aalborg University Hospital	Aalborg	Denmark
2	Aarhus University Hospital	Aarhus	Denmark
3	Gødstrup Regional Hospital	Gødstrup	Denmark
4	Horsens Regional Hospital	Horsens	Denmark
5	Randers Regional Hospital	Randers	Denmark
6	Viborg Regional Hospital	Viborg	Denmark

Sponsors and Collaborators

Lars Wiuff Andersen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Lars Wiuff Andersen, Associate Professor, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT06047119

Other Study ID Numbers:

00005

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 22, 2023