NCT01057420

Brief Summary

Prospective, controlled, randomized crossover volunteer study to investigate the effect of hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on blood coagulation, especially platelet function, as measured by thrombelastography. According to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by means of reactive oxygen species. This study aims at investigating a possible pro-coagulant effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are integrated.

  • Trial with medical device

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_4 healthy-volunteers

Timeline
Completed

Started Apr 2009

Typical duration for phase_4 healthy-volunteers

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

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

11 months

First QC Date

January 25, 2010

Last Update Submit

August 23, 2010

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • maximum amplitude in thrombelastography

    1 hour

Study Arms (1)

Inhalation of 80% Oxygen

OTHER

Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours

Drug: oxygen inhalation

Interventions

oxygen inhalationDRUG

Inhalation of 80% oxygen via face mask

Inhalation of 80% Oxygen

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • informed consent; no coagulation disorder or other illnesses;
  • non-smoker;
  • women: no pharmacological contraception, negative pregnancy test;
  • years old; no medication; no acute or chronic airway problems;
  • for 24 hours before study: no extreme physical activity, no polyphenol-containing food (red wine, apples, cabbage, garlic);
  • for 48 hours: no caffeine-containing drinks, no dark chocolate.

You may not qualify if:

  • allergy or incompatibility to substances/materials applied in the study;
  • very thin veins/arteries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Intensive Care Medicine

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Interventions

Oxygen Inhalation Therapy

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Johannes Wacker, MD

    Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

  • Reto Stocker, Prof., MD

    Surgical Intensive Care Medicine, UniversitaetsSpital Zurich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 27, 2010

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

CH(1)