NCT04612270

Brief Summary

The presented study is an experimental in-vitro study without intervention in-vivo. The effects of nitric oxide and prostacyclins, 5-hydroxymethylfurfural and alpha-ketoglutarate, volatile anaesthetics on haemoglobin oxygen (HbO2) affinity will be investigated in-vitro. Venous blood samples of 20 healthy young volunteers (10 female, 10 male) will be collected twice in the period of one week. Informed consent will be given. Every blood collection will be accompanied by a venous blood gas analysis. The blood samples will be transferred to the laboratory for in-vitro recording of the complete oxygen dissociation curve (ODC). A newly developed in-vitro method will be used. On the first study day the blood samples will be exposed to three different concentrations of nitric oxide during the measurement, followed by two different vapourized prostacyclins. In addition, different concentrations of 5-hydroxymethylfurfural and alpha-ketoglutarate will be given to the blood samples for ODC recording. On the second study day the dose dependent effects of three different volatile anaesthetics will be investigated by exposing the blood samples to these drug while the measurements. Following these ODC recordings, aliquots of the blood samples will be frozen and investigated for storage related changes in HbO2 affinity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 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

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

October 27, 2020

Last Update Submit

September 7, 2021

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

  • P50

    Partial pressure of oxygen, at which 50% of haemoglobin is saturated with oxygen.

    One day

Secondary Outcomes (1)

  • Hill coefficient

    One day

Study Arms (1)

Participants for blood collection

EXPERIMENTAL

The blood samples of all participants will be treated equally according to the study protocol. No intervention in-vivo.

Other: Venous blood collection

Interventions

Venous blood collectionOTHER

Two venous blood collections in within one week. No drug-related intervention in-vivo.

Participants for blood collection

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details10 female and 10 male participants.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent
  • ASA 1 (American Society of Anesthesiologists classification)

You may not qualify if:

  • Any drug intake within 10 days prior to blood collection
  • Smoking
  • Haemoglobinopathy
  • Acute inflammatory disease within 14 days prior to blood collection
  • Pregnancy or breastfeeding
  • Severe trauma or blood loss within 14 days prior to blood collection
  • Participation in any other clinical study
  • High altitude sojourn for several days (\> 3,000 m) within four weeks prior to blood collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Critical Care Medicine

Innsbruck, Tyrol, 6122, Austria

Location

Related Publications (1)

  • Ronzani M, Woyke S, Mair N, Gatterer H, Oberacher H, Plunser D, Haller T, Strohle M, Rugg C. The effect of desflurane, isoflurane and sevoflurane on the hemoglobin oxygen dissociation curve in human blood samples. Sci Rep. 2022 Aug 10;12(1):13633. doi: 10.1038/s41598-022-17789-6.

    PMID: 35948604DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mathias Ströhle, MD

    MUI, Department of Anaesthesiology and Critical Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

November 4, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)