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Applicability of Techniques of Lung Expansion

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ClinicalTrials.gov Identifier: NCT02613832
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Caio César Araújo Morais, Universidade Federal de Pernambuco

Study Description
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Brief Summary:
The survival of patients with lesions in the central nervous system is usually accompanied by physical and mental sequelae. These impairments favor the prolonged restriction to the bed, which may contribute with changes in respiratory function. In this context, lung re-expansion techniques are used to prevent or treat the various respiratory complications.

Condition or disease Intervention/treatment Phase
Stroke Other: EPAP Other: Breath Stacking Not Applicable

Detailed Description:
The survival of patients with lesions in the Central Nervous System is usually accompanied by physical and mental permanents sequelae. This impairment of cognitive status associated with motor injury favors prolonged restriction of these patients to the bed, which may contribute to the emergence of other health damages. In the clinical practice, lung expansion techniques has been used as a prophylaxis and treatment of respiratory conditions that involve volumetric reductions. However, the deficit of awareness and cooperation difficult the use of several therapeutic resources. There are few interventions that could be proposed due to no need the collaboration to be performed, such as Breath Stacking technique (BS) and Expiratory Positive Airway Pressure (EPAP). The BS is characterized by execution of inspiratory cycles through a one way valve, which allows stacked volume of gas during each inspiration, until it reaches values approximate to maximum inspiratory capacity. While in the EPAP, alveolar pressure is elevated to breath against a expiratory flow resistance generated by a spring load valve. The effects on lung volume promoted BS and EPAP can be safely measured using an electrical impedance tomography (EIT). This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. The effects on lung volume promoted BS and EPAP can be safely measured using an EIT monitor. This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. Until this moment, there is not description about the effect of lung expansion techniques on regional lung parameters.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Immediate Effect of Expiratory Positive Airway Pressure and Breath Stacking in Non-cooperative Patients Detected by Electrical Impedance Tomography
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: EPAP Group
The EPAP devices increase the alveolar pressure. This effect is obtained through valves that generate a resistance to airflow during expiration.
 Other: EPAP
The EPAP will be applied with a Spring Load Valve Resistor (Vital Signs, Totowa, NJ, USA), adjusted with a pressure of 10 cmH2O. The Spring Load Valve Resistor will be connected to the expiratory branch of the T-tube. Duration of intervention: 5 minutes.
Other Name: Expiratory Positive Airway Pressure
Experimental: Breath Stacking Group
The Breath Stacking consists on the implementation of subsequent inspiratory efforts through a one way valve, which allows stacked volume of gas during each inspiration, until it reaches a maximum lung volume.
 Other: Breath Stacking
The BS will be performed by a T-tube with a one-way inspiratory valve and the expiratory branch occluded. The expiratory occlusion is maintain until observed the presence of a plateau in the impedance plethysmogram by EIT, which corresponds to the absence of inspired air displacement or when a maximum time of 40 seconds was attained. Durantion of intervention:Three BS interventions will be performed at one minute intervals between them.
Other Name: Air Stacking


Outcome Measures
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Primary Outcome Measures :
  1. Regional Lung Aeration [ Time Frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention. ]
    Change in Regional Lung Aeration (difference between the End-Expiratory Lung Impedance before and post-intervention). Each image along the time represent the relative change in impedance distribution within the transverse section of the chest, from the first scan (before intervention) to current scan. The pixel values are express as percentage changes of local impedance.


Secondary Outcome Measures :
  1. Regional Lung Ventilation [ Time Frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention. ]
    Change in Regional Lung Ventilation (difference between end-inspiratory and end-expiratory lung impedance before and post-intervention).

  2. Heart Rate [ Time Frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention. ]
    Change in Heart Rate (beats per minute).

  3. Mean Arterial Pressure [ Time Frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention. ]
    Change in Mean Arterial Pressure (mmHg)

  4. Respiratory Rate [ Time Frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention. ]
    Change in Respiratory Rate (breath per minute)

  5. Periferic Saturation of Oxygen [ Time Frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention. ]
    Change in Periferic Saturation of Oxygen (fraction of oxygen-saturated hemoglobin relative to total hemoglobin).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Patients undergoing neurosurgery restricted to bed for more than 14 days;
  2. Aged between 18 and 65 years;
  3. Glasgow Coma Scale < 10 points;
  4. Breathing spontaneously through the tracheostomy tube;
  5. No respiratory infection;
  6. Chest circumference between 88 and 98 centimeters;

Exclusion criteria:

  1. Presence of chronic lung diseases;
  2. Chest deformity;
  3. Rib fracture;
  4. Asymmetrical chest expansion;
  5. Abdomen distension;
  6. Spasticity in any hemisphere with Ashworth Scale score more than 2 points for upper limbs;
  7. Uncoordinated movements of the limbs;
  8. Cardiorespiratory instability (heart rate < 60 or > 120 bpm; respiratory rate > 35 ipm; mean arterial pressure < 60 mmHg or > 120 mmHg; oxygen saturation < 90%).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613832


Locations
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Brazil
Hospital of Clinics of the Federal University of Pernambuco
Recife, PE - Pernambuco, Brazil, 50670330
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Study Chair: Caio César A Morais, Master Universidade Federal de Pernambuco
Study Chair: Shirley L Campos, PHD Universidade Federal de Pernambuco
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Caio César Araújo Morais, Specialist in cardiopulmonary physiotherapy, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02613832    
Other Study ID Numbers: Caio01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Keywords provided by Caio César Araújo Morais, Universidade Federal de Pernambuco:
Noncooperative patients