- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108585
Efficacy of Different Respiratory Methods in Intensive Care
Investigation of the Efficacy of Different Respiratory Methods in the Treatment of Patients With Respiratory Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Respiratory insufficiency is frequently present in patients who are admitted to intensive care units and respiratory support is provided through respiratory device. Respiratory support can be given by intubating the patient or without intubating the patient.
It is a procedure with intubation complications and stimulation of the sympathetic system as well as tongue, lip and tooth injuries. In recent years, non-invasive respiratory support can be given with the aid of a mask or nasal cannula without intubation, which has stable hemodynamics, no secretion, can cough, adhere to orders, no face, neck and head injuries (difficulty in mask application) and the use of this method is rapidly increasing in intensive care units.
Non-invasive respiratory support can be provided by CPAP method. In this method, positive pressure blended oxygen can be given to the patient by using an oranasal mask. In the literature, the use of non-invasive CPAP has been reported to be the gold standard for respiratory failure, particularly in COPD and immunosuppressed patients. CPAP method is available as standard in mechanical ventilators used in intensive care. The major disadvantage of CPAP is the discomfort caused by the mask attached to the patient's face.
In recent years, high-flow oxygen therapy (HFO) has been introduced, and in this mode, high-flow oxygen therapy is applied to the patient with high frequency nasal route and especially successful in COPD patients. In this method, patient comfort is higher since there is no mask attachment. The HFO device is not available in the intensive care unit and is planned to be purchased with the support of TUBAP.
In our intensive care unit, patients are primarily given non-invasive respiratory support. Follow-up during this support is extremely important. Whether the non-invasive respiratory support is sufficient is determined by follow-up. Following non-invasive respiratory support, patients are followed up, respiratory frequency rises above 30-35 in the first hour, peripheral oxygen saturation <90% decrease, systolic blood pressure increase 20%, 180 mmHg rise below 90 mmHg In case of an increase in heart rate of 20 beats / min, heart rate of more than 140 beats per minute, tachypnea, intercostal withdrawal, agitation and distress, the patient is intubated and respiratory support is applied invasively. 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 two different non-invasive breathing methods.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Edirne, Turkey, 22030
- Trakya University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Inclusion Criteria:
- 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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- To be under 18 years
- pregnant women
- nursing
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HFO group
HFO therapy
|
HFO therapy from mechanical ventilation
|
CPAP group
CPAP therapy
|
CPAP therapy from mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate as per minute
Time Frame: Change from Baseline Heart rate as per minute at 1.hour
|
variable 1
|
Change from Baseline Heart rate as per minute at 1.hour
|
peripheral oxygen saturation as % value
Time Frame: Change from Baseline peripheral oxygen saturation as % value at 1.hour
|
variable 2
|
Change from Baseline peripheral oxygen saturation as % value at 1.hour
|
arterial blood pressure as mmHg value
Time Frame: Change from Baseline arterial blood pressure as mmHg value at 1.hour
|
variable 3
|
Change from Baseline arterial blood pressure as mmHg value at 1.hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUTF-BAEK 2016-197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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