Respiratory and Hemodynamic Targets During General Anesthesia

NCT ID: NCT06047119

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-09

Study Completion Date

2025-04-24

Brief Summary

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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

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Conditions

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Patients Undergoing General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Blood pressure

Intervention Type PROCEDURE

Blood pressure targets during general anesthesia and 2 hours after

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

Group Type EXPERIMENTAL

Blood pressure

Intervention Type PROCEDURE

Blood pressure targets during general anesthesia and 2 hours after

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

Group Type EXPERIMENTAL

Blood pressure

Intervention Type PROCEDURE

Blood pressure targets during general anesthesia and 2 hours after

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

Group Type EXPERIMENTAL

Blood pressure

Intervention Type PROCEDURE

Blood pressure targets during general anesthesia and 2 hours after

Positive end expiratory pressure 5 cm H20 during general anesthesia

Group Type EXPERIMENTAL

Positive end expiratory pressure

Intervention Type PROCEDURE

Positive end expiratory pressure during general anesthesia

Positive end expiratory pressure 8 cm H20 during general anesthesia

Group Type EXPERIMENTAL

Positive end expiratory pressure

Intervention Type PROCEDURE

Positive end expiratory pressure during general anesthesia

Positive end expiratory pressure 10 cm H20 during general anesthesia

Group Type EXPERIMENTAL

Positive end expiratory pressure

Intervention Type PROCEDURE

Positive end expiratory pressure during general anesthesia

Tidal volume 5 ml/kg during general anesthesia

Group Type EXPERIMENTAL

Tidal volume

Intervention Type PROCEDURE

Tidal volume during general anesthesia

Tidal volume 8 ml/kg during general anesthesia

Group Type EXPERIMENTAL

Tidal volume

Intervention Type PROCEDURE

Tidal volume during general anesthesia

Tidal volume 10 ml/kg during general anesthesia

Group Type EXPERIMENTAL

Tidal volume

Intervention Type PROCEDURE

Tidal volume during general anesthesia

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

Group Type EXPERIMENTAL

Fraction of inspired oxygen

Intervention Type PROCEDURE

Fraction of inspired oxygen during general anesthesia and 2 hours after

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

Group Type EXPERIMENTAL

Fraction of inspired oxygen

Intervention Type PROCEDURE

Fraction of inspired oxygen during general anesthesia and 2 hours after

Interventions

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Blood pressure

Blood pressure targets during general anesthesia and 2 hours after

Intervention Type PROCEDURE

Positive end expiratory pressure

Positive end expiratory pressure during general anesthesia

Intervention Type PROCEDURE

Tidal volume

Tidal volume during general anesthesia

Intervention Type PROCEDURE

Fraction of inspired oxygen

Fraction of inspired oxygen during general anesthesia and 2 hours after

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lars Wiuff Andersen

OTHER

Sponsor Role lead

Responsible Party

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Lars Wiuff Andersen

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Gødstrup Regional Hospital

Gødstrup, , Denmark

Site Status

Horsens Regional Hospital

Horsens, , Denmark

Site Status

Randers Regional Hospital

Randers, , Denmark

Site Status

Viborg Regional Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 35675085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35703253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35797424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35924389 (View on PubMed)

Other Identifiers

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00005

Identifier Type: -

Identifier Source: org_study_id

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