Chest Physiotherapy in Tracheotomized Patients
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEP
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Breathing exercises, Intensive care, Physical therapy modalities, Physiotherapy, Respiratory distress syndrome, adult, Ventilator weaning
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Positive expiratory pressure (PEP)
Arm Description
PEP 10 cmH2O 15 min
Outcomes
Primary Outcome Measures
Change in PaO2
Change from baseline arterial partial pressure of oxygen
Secondary Outcome Measures
Change in PaCO2
Change from baseline arterial partial pressure of carbon dioxide
Change in peripheral oxygen saturation (SpO2)
Change from baseline in SpO2
Change in respiratory frequency
Change from baseline in respiratory frequency
Change in mean arterial pressure (MAP)
Change from baseline in MAP
Change in heart rate
Change from baseline in heart rate
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04435535
Brief Title
Chest Physiotherapy in Tracheotomized Patients
Official Title
Immediate Effects of Chest Physiotherapy in Tracheotomized Patients With Acute Respiratory Distress Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Breathing exercises, Intensive care, Physical therapy modalities, Physiotherapy, Respiratory distress syndrome, adult, Ventilator weaning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive expiratory pressure (PEP)
Arm Type
Other
Arm Description
PEP 10 cmH2O 15 min
Intervention Type
Procedure
Intervention Name(s)
PEP
Intervention Description
Positive expiratory pressure 10 cmH2O 15 min
Primary Outcome Measure Information:
Title
Change in PaO2
Description
Change from baseline arterial partial pressure of oxygen
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Secondary Outcome Measure Information:
Title
Change in PaCO2
Description
Change from baseline arterial partial pressure of carbon dioxide
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Title
Change in peripheral oxygen saturation (SpO2)
Description
Change from baseline in SpO2
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Title
Change in respiratory frequency
Description
Change from baseline in respiratory frequency
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Title
Change in mean arterial pressure (MAP)
Description
Change from baseline in MAP
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Title
Change in heart rate
Description
Change from baseline in heart rate
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
Title
Change in Borg´s Category Ratio 10scale (Borg CR 10 scale) from baseline
Description
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).
Time Frame
Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Chest Physiotherapy in Tracheotomized Patients
We'll reach out to this number within 24 hrs