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Chest Physiotherapy in Tracheotomized Patients

Immediate Effects of Chest Physiotherapy in Tracheotomized Patients With Acute Respiratory Distress Syndrome.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04435535
Enrollment
17
Registered
2020-06-17
Start date
2012-02-01
Completion date
2017-03-31
Last updated
2020-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

Breathing exercises, Intensive care, Physical therapy modalities, Physiotherapy, Respiratory distress syndrome, adult, Ventilator weaning

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.

Interventions

PROCEDUREPEP

Positive expiratory pressure 10 cmH2O 15 min

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in PaO2Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.Change from baseline arterial partial pressure of oxygen

Secondary

MeasureTime frameDescription
Change in peripheral oxygen saturation (SpO2)Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.Change from baseline in SpO2
Change in respiratory frequencyBaseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.Change from baseline in respiratory frequency
Change in PaCO2Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.Change from baseline arterial partial pressure of carbon dioxide
Change in heart rateBaseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.Change from baseline in heart rate
Change in Borg´s Category Ratio 10scale (Borg CR 10 scale) from baselineBaseline. 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).
Change in mean arterial pressure (MAP)Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.Change from baseline in MAP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026