NCT04108585

Brief Summary

Peripheral oxygen saturation, non-invasive blood pressure, heart rate, respiratory rate and respiratory rate are routinely used in our intensive care unit in the follow-up of patients. In the study, the patient papers will be followed and the respiratory support of the patients will be recorded and all follow-ups will be made from the patient follow-up chart. The aim of this study is to compare the CPAP and HFO methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

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

November 30, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

September 3, 2019

Last Update Submit

September 27, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Heart rate as per minute

    variable 1

    Change from Baseline Heart rate as per minute at 1.hour

  • peripheral oxygen saturation as % value

    variable 2

    Change from Baseline peripheral oxygen saturation as % value at 1.hour

  • arterial blood pressure as mmHg value

    variable 3

    Change from Baseline arterial blood pressure as mmHg value at 1.hour

Study Arms (2)

HFO group

HFO therapy

Procedure: HFO therapy

CPAP group

CPAP therapy

Procedure: CPAP therapy

Interventions

HFO therapyPROCEDURE

HFO therapy from mechanical ventilation

HFO group
CPAP therapyPROCEDURE

CPAP therapy from mechanical ventilation

CPAP group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inclusion Criteria: 1. They have completed the age of 18 2. need oxygen therapy due to respiratory failure 3. Hemodynamic stability 4. Coughing 5. follow orders 6. face, neck and head without injury

You may qualify if:

  • They have completed the age of 18
  • need oxygen therapy due to respiratory failure
  • Hemodynamic stability
  • Coughing
  • follow orders
  • face, neck and head without injury

You may not qualify if:

  • To be under 18 years
  • pregnant women
  • nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (1)

  • Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.

    PMID: 25558703BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member of Intensive Care

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 30, 2019

Study Start

November 30, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations