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Completed

NCT Number: NCT04108585

Efficacy of Different Respiratory Methods in Intensive Care

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University

Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFO therapy

Procedure

HFO therapy from mechanical ventilation

CPAP therapy

Procedure

CPAP therapy from mechanical ventilation

Primary outcomes

  1. Heart rate as per minute

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

    variable 1

  2. peripheral oxygen saturation as % value

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

    variable 2

  3. arterial blood pressure as mmHg value

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

    variable 3

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Investigation of the Efficacy of Different Respiratory Methods in the Treatment of Patients With Respiratory Failure

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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