Respiratory InsufficiencyNCT04108585
Efficacy of Different Respiratory Methods in Intensive Care
An observational study of Respiratory Insufficiency, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- HFO therapy and CPAP therapy
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2016to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- To be under 18 years
- pregnant women
- nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Efficacy of Different Respiratory Methods in the Treatment of Patients With Respiratory Failure
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.
Read the 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.
- Conditions
- Respiratory Insufficiency
- Being tested
- HFO therapy, CPAP therapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFO therapyProcedure or surgery
HFO therapy from mechanical ventilation
CPAP therapyProcedure or surgery
CPAP therapy from mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| HFO group | HFO therapy Receives: Procedure: HFO therapy | |
| CPAP group | CPAP therapy Receives: Procedure: CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate as per minute
variable 1
Measured: Change from Baseline Heart rate as per minute at 1.hour
peripheral oxygen saturation as % value
variable 2
Measured: Change from Baseline peripheral oxygen saturation as % value at 1.hour
arterial blood pressure as mmHg value
variable 3
Measured: Change from Baseline arterial blood pressure as mmHg value at 1.hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start30 Nov 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Mehmet Turan Inal, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108585
- Sponsor's protocol ID
- TUTF-BAEK 2016-197
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25558703
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Different Respiratory Methods in the Treatment of Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT04108585
- Acronym / sponsor ID
- TUTF-BAEK 2016-197
- Conditions
- Respiratory Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFO group | – | Procedure: HFO therapyHFO therapy |
| CPAP group | – | Procedure: CPAP therapyCPAP therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- They have completed the age of 18
- need oxygen therapy due to respiratory failure
- Hemodynamic stability
- Coughing
- follow orders
Key exclusion criteria (3 listed)
- To be under 18 years
- pregnant women
- nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFO therapyHFO therapy from mechanical ventilation | Procedure or surgery | HFO group |
| CPAP therapyCPAP therapy from mechanical ventilation | Procedure or surgery | CPAP group |
Primary outcome
Heart rate as per minute
Time frame: Change from Baseline Heart rate as per minute at 1.hour
variable 1
peripheral oxygen saturation as % value
Time frame: Change from Baseline peripheral oxygen saturation as % value at 1.hour
variable 2
arterial blood pressure as mmHg value
Time frame: Change from Baseline arterial blood pressure as mmHg value at 1.hour
variable 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Background: PubMed 25558703Brotfain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate as per minute (time frame: Change from Baseline Heart rate as per minute at 1.hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.