NCT04958668

Brief Summary

Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids. The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

June 28, 2021

Last Update Submit

January 8, 2024

Conditions

Valve Heart DiseaseAwakening Early

Outcome Measures

Primary Outcomes (1)

  • Time to extubation

    Time from admission on ICU until awakening and Extubation.

    through study completion, an average of 2 days

Secondary Outcomes (11)

  • Time to neurocognitive assessability

    through study completion, an average of 2 days

  • Required setup time of the intensive care workplace

    through study completion, up to 24 hours

  • Factor related to the course of intensive care: blood loss

    through study completion, an average of 24 hours

  • Factor related to the course of intensive care: kidney injury

    through study completion, an average of 24 hours

  • Factor related to the course of intensive care: acid-base balance

    through study completion, an average of 24 hours

  • +6 more secondary outcomes

Study Arms (2)

Volatile procedere

ACTIVE COMPARATOR

Intensive care treatment with demand-adapted sedation with volatile anaesthetics

Other: Post-operative intensive care using volatile sedation

Conventional procedere

NO INTERVENTION

Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives

Interventions

Post-operative intensive care using volatile sedationOTHER

Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management..

Volatile procedere

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Valve reconstruction or valve replacement
  • Must be capable to giving written consent

You may not qualify if:

  • Intolerance to volatile anaesthetics (e.g. malignant hyperthermia)
  • Severe obstructive pulmonary disease
  • Extended aortic arch or ascending aorta surgery
  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (2)

  • Flinspach AN, Raimann FJ, Kaiser P, Pfaff M, Zacharowski K, Neef V, Adam EH. Volatile versus propofol sedation after cardiac valve surgery: a single-center prospective randomized controlled trial. Crit Care. 2024 Apr 5;28(1):111. doi: 10.1186/s13054-024-04899-y.

    PMID: 38581030DERIVED

  • Flinspach AN, Herrmann E, Raimann FJ, Zacharowski K, Adam EH. Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial. BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804.

    PMID: 35197356DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Armin N Flinspach, M.D.

    JWGoethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 12, 2021

Study Start

November 1, 2021

Primary Completion

August 28, 2023

Study Completion

December 1, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)