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Completed

NCT Number: NCT04435535

Chest Physiotherapy in Tracheotomized Patients

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP

Procedure

Positive expiratory pressure 10 cmH2O 15 min

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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).

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 17, 2020
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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