search
Back to results

Chest Physiotherapy in Tracheotomized Patients

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEP
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 2, 2020
    Last Updated
    June 14, 2020
    Sponsor
    Linkoeping University
    search

    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