Acute Respiratory Distress SyndromeNCT04435535
Chest Physiotherapy in Tracheotomized Patients
A study testing PEP in people with Acute Respiratory Distress Syndrome, run by Linkoeping University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- PEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 31 Mar 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack of informed consent
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- PEP
- Keywords
- Breathing exercises, Intensive care, Physical therapy modalities, Physiotherapy, Respiratory distress syndrome, adult, Ventilator weaning
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPProcedure or surgery
Positive expiratory pressure 10 cmH2O 15 min
| Study group | Role | What they receive |
|---|---|---|
| Positive expiratory pressure (PEP) | Other | PEP 10 cmH2O 15 min Receives: Procedure: PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaO2
Change from baseline arterial partial pressure of oxygen
Measured: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Secondary outcomes (6)
Change in PaCO2
Change from baseline arterial partial pressure of carbon dioxide
Measured: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Change in peripheral oxygen saturation (SpO2)
Change from baseline in SpO2
Measured: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Change in respiratory frequency
Change from baseline in respiratory frequency
Measured: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Change in mean arterial pressure (MAP)
Change from baseline in MAP
Measured: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Change in heart rate
Change from baseline in heart rate
Measured: 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
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).
Measured: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Feb 2012
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jenny Örman, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435535
- Sponsor's protocol ID
- PEPpåtrack
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Chest Physiotherapy in Tracheotomized Patients With Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT04435535
- Acronym / sponsor ID
- PEPpåtrack
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Breathing exercises, Intensive care, Physical therapy modalities, Physiotherapy, Respiratory distress syndrome, adult, Ventilator weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 17 Jun 2020 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive expiratory pressure (PEP) | Other | Procedure: PEPPEP 10 cmH2O 15 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack of informed consent
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 |
|---|---|---|
| PEPPositive expiratory pressure 10 cmH2O 15 min | Procedure or surgery | Positive expiratory pressure (PEP) |
Primary outcome
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
6 secondary outcomes
Change in PaCO2
Time frame: 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 in respiratory frequency
Time frame: 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 in heart rate
Time frame: 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.
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 17 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PEP in people with Acute Respiratory Distress Syndrome, run by Linkoeping University.
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 5 inclusion and 1 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 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in PaO2 (time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2020.