- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435535
Chest Physiotherapy in Tracheotomized Patients
Immediate Effects of Chest Physiotherapy in Tracheotomized Patients With Acute Respiratory Distress Syndrome.
Positive expiratory pressure (PEP) breathing is common for treatment of different lung diseases and can increase lung volume and increase elimination of secretion from the airways. Today there is no evidence whether the treatment is effective or not for patients in the intensive care unit. The purpose of this study is to evaluate if PEP breathing can increase oxygenation for patients in the intensive care unit during weaning from the ventilator after acute respiratory distress syndrome.
PEP breathing will be applied on the tracheal cannula for 15 minutes. Measure of the PEP effect will be done before, during and for 20 minutes after PEP breathing.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Procedure:
To achieve steady state, all subjects are positioned in a semi-recumbent position (30°) for 60 minutes before the start of the intervention and remain in that position during the entire investigation. Subjects are instructed to avoid talking and movements during both steady state and measurements. Airway suctioning (up to 20 kPa) through the tracheal cannula is performed only if there is risk for tube obstruction or if SpO2 decreases below 90%. Frequency of airway suctioning, and number of coughs during the study time are registered. An extra pre-intervention measurement is performed 15 minutes after the first to increase the validity of baseline measurements and control for changes in measured variables due to spontaneous variations.
A PEP device consisting of a one-way valve and exchangeable resistance nipples is used during the PEP breathing treatment. The resistance nipple is chosen at the start of the intervention aiming at an airway pressure of 10-15 cmH2O during tidal breathing (measured with a calibrated manometer). The duration of the PEP treatment is 15 minutes. Complementary oxygen is delivered at the same amount as before the intervention.
Measurements:
The primary outcome is PaO2. Five separate arterial blood samples of 0.7-1.5 ml each (altogether 3.5-7.5 ml for each subject) are drawn from an existing arterial catheter in the radial artery in the left or the right arm by nurses at the ward, and directly analysed.
Subject characteristics are registered from the clinical records, including gender, age, body mass index (BMI), smoking history, duration of invasive ventilation, and length of ICU stay.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Tracheostomized participants
- ≥18 years old
- Moderate or severe ARDS during the ICU period, according to the Berlin definition.
- Ability to maintain PaO2 ≥ 67.5mmHg, with supplementary oxygen if needed, during spontaneous breathing for at least three consecutive hours.
- Normal curvature of the spine.
Exclusion Criteria:
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Positive expiratory pressure (PEP)
PEP 10 cmH2O 15 min
|
Positive expiratory pressure 10 cmH2O 15 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PaO2
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change from baseline arterial partial pressure of oxygen
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PaCO2
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change from baseline arterial partial pressure of carbon dioxide
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change in peripheral oxygen saturation (SpO2)
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change from baseline in SpO2
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change in respiratory frequency
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change from baseline in respiratory frequency
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change in mean arterial pressure (MAP)
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change from baseline in MAP
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change in heart rate
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change from baseline in heart rate
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Change in Borg´s Category Ratio 10scale (Borg CR 10 scale) from baseline
Time Frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Borg CR-10 scale is an eleven point nominal scale that measures patient perceived breathlessness.
A higher number indicates a greater breathlessness.
0=no breathlessness.
10 = very very high breathlessness (almost maximal).
|
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEPpåtrack
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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