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Volatiles in Critical Care After Free Flap Surgery.

Sponsor
Goethe University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05707884
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
40.5
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: critical care management
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery.
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Material consumption [Inventory of the required materials until the end of sedation (90 hours)]

    Required equipment and disposable materials related to the treatment interval as well as their monetary value in euros or US dollars.

  2. Working time expenditure [Inventory of the required time until the end of sedation (90 hours)]

    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.

Secondary Outcome Measures

  1. Delir [Within the intensive care stay (5 days)]

    Occurrence of delirium in the intensive care setting

  2. Time to awake [Within the intensive care stay (5 days)]

    Time required beyond the intended 72 hours of sedation for the patient to awaken

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Frankfurt Frankfurt Hessen Germany 60590

Sponsors and Collaborators

  • Goethe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Armin N. Flinspach, intensivist, Goethe University
ClinicalTrials.gov Identifier:
NCT05707884
Other Study ID Numbers:
  • 2022-1040
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 1, 2023