MedDataX Logo

Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy

NCT ID: NCT01300845

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oxygen Inhalation Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Humidification

Group Type ACTIVE_COMPARATOR

Humidification

Intervention Type PROCEDURE

From randomization, oxygen therapy is humidified

No Humidification

Group Type EXPERIMENTAL

No Humidification

Intervention Type PROCEDURE

oxygen therapy is never humidified

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Humidification

From randomization, oxygen therapy is humidified

Intervention Type PROCEDURE

No Humidification

oxygen therapy is never humidified

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Admission in Intensive Care Unit
* Oxygen therapy started for less than two hours in ICU

Exclusion Criteria

* Age under 18
* Pregnancy
* Participation in other trials with the same endpoints
* absence of registration in french health care system
* patient protected by law
* tracheotomised or intubated patient
* Patient with non invasive ventilation
* Oxygen therapy started for more than two hours in ICU
* moribund
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHRI 2010-02

Identifier Type: -

Identifier Source: org_study_id