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NCT Number: NCT04894019

Effect of Continuous Invasive Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery

This is a randomized trial (1) investigating whether continuous invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.

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Key information

Conditions

Blood Pressure Perioperative Hypotension Postinduction Hypotension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients...

  • at least 18 years of age
  • scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study

Exclusion criteria

  • Clinical indication to insert the arterial catheter before anesthetic induction ("awake arterial catheter"; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device)
  • emergency surgery
  • American Society of Anesthesiologists physical status classification V or VI
  • need for femoral artery catheterization
  • heart rhythms other than sinus rhythm.

Treatment and study plan

Continuous invasive blood pressure monitoring

Device

Continuous invasive blood pressure monitoring using an arterial catheter

Intermittent non-invasive blood pressure monitoring

Device

Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry

Primary outcomes

  1. Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.

    Time frame: during the induction period

Secondary outcomes

  1. Effect of continuous invasive arterial blood pressure monitoring on cardiac output within the first 15 minutes of anesthetic induction between the intervention and the control group.

    Time frame: during the induction period

  2. Effect of continuous invasive arterial blood pressure monitoring on stroke volume within the first 15 minutes of anesthetic induction between the intervention and the control group.

    Time frame: during the induction period

  3. Effect of continuous invasive arterial blood pressure monitoring on heart rate within the first 15 minutes of anesthetic induction between the intervention and the control group.

    Time frame: during the induction period

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

The Effect of Continuous Invasive Arterial Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery (AWAKE Trial): a Randomized Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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