Respiratory and Hemodynamic Targets During General Anesthesia (GA-TARGETS)

Lars Wiuff Andersen

Status: Completed

Conditions: Patients Undergoing General Anesthesia

Treatments: Procedure: Positive end expiratory pressure; Procedure: Blood pressure; Procedure: Tidal volume; Procedure: Fraction of inspired oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06047119

00005

Details and patient eligibility

About

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.

Enrollment: 485 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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485 participants in 12 patient groups

Mean arterial blood pressure above 60 mmHg during general anesthesia and 2 hours after

Experimental group

Treatment:

Procedure: Blood pressure

Mean arterial blood pressure above 70 mmHg during general anesthesia and 2 hours after

Experimental group

Treatment:

Procedure: Blood pressure

Mean arterial blood pressure above 80 mmHg during general anesthesia and 2 hours after

Experimental group

Treatment:

Procedure: Blood pressure

Systolic blood pressure above 90% of baseline during general anesthesia and 2 hours after

Experimental group

Treatment:

Procedure: Blood pressure

Positive end expiratory pressure 5 cm H20 during general anesthesia

Experimental group

Treatment:

Procedure: Positive end expiratory pressure

Positive end expiratory pressure 8 cm H20 during general anesthesia

Experimental group

Treatment:

Procedure: Positive end expiratory pressure

Positive end expiratory pressure 10 cm H20 during general anesthesia

Experimental group

Treatment:

Procedure: Positive end expiratory pressure

Tidal volume 5 ml/kg during general anesthesia

Experimental group

Treatment:

Procedure: Tidal volume

Tidal volume 8 ml/kg during general anesthesia

Experimental group

Treatment:

Procedure: Tidal volume

Tidal volume 10 ml/kg during general anesthesia

Experimental group

Treatment:

Procedure: Tidal volume

Fraction of inspired oxygen 30% during general anesthesia and 2 hours after

Experimental group

Treatment:

Procedure: Fraction of inspired oxygen

Fraction of inspired oxygen 80% during general anesthesia and 2 hours after

Experimental group

Treatment:

Procedure: Fraction of inspired oxygen