Volatiles in Critical Care After Free Flap Surgery

Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery

Patients undergoing complex free flap surgery are randomised to volatile or intravenous sedation in terms of subsequent intensive care sedation, based on the in-hospital standard of care. For study purposes, differences in management (set-up times, change of filters, etc.) will be investigated in relation to accelerated awakening and possibly improved neurocognition after the end of sedation.

Study Overview

• Status: Recruiting
• Conditions: Sedation Set-up Time; Additional Time Required for Volatile Sedation
• Intervention / Treatment: Other: critical care management

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Recruiting
      • University Hospital Frankfurt
      • Contact: Armin N Flinspach, MD; Phone Number: 0049-69-6301-5868; Email: armin.flinspach@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Free flap surgery
• Patient capable of giving informed written consent

Exclusion Criteria:

• Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
• Severe obstructive pulmonary disease
• Pre-existing severe neurocognitive disorder
• Age <18 years (minors)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: volatile sedation; Patients receive volatile sedation for the intended 72 hours of deep sedation after complex free flap surgery.	Other: critical care management; The different sedation methods result in considerable differences in terms of set-up costs and the management of the patient, which will be examined in a direct comparison.
No Intervention: intravenous sedation; Patients receive intravenous sedation (e.g. propofol) for the intended 72 hours of deep sedation after complex free flap surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Material consumption	Required equipment and disposable materials related to the treatment interval as well as their monetary value in euros or US dollars.	Inventory of the required materials until the end of sedation (90 hours)
Working time expenditure	Time spent by nurses or physicians on the specific sedation procedure, as well as the corresponding financial value based on nationally applicable collective wage agreements in euros or US dollars.	Inventory of the required time until the end of sedation (90 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delir	Occurrence of delirium in the intensive care setting	Within the intensive care stay (5 days)
Time to awake	Time required beyond the intended 72 hours of sedation for the patient to awaken	Within the intensive care stay (5 days)

Collaborators and Investigators

• Sponsor: Goethe University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 22, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-1040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No