Applicability of Techniques of Lung Expansion

Stroke Clinical Trial

Official title:

Immediate Effect of Expiratory Positive Airway Pressure and Breath Stacking in Non-cooperative Patients Detected by Electrical Impedance Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613832
• Other study ID #: Caio01
• Status: Completed
• Phase: N/A
• First received: October 25, 2013
• Last updated: November 22, 2015
• Start date: August 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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%).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital of Clinics of the Federal University of Pernambuco	Recife	PE - Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Baker WL, Lamb VJ, Marini JJ. Breath-stacking increases the depth and duration of chest expansion by incentive spirometry. Am Rev Respir Dis. 1990 Feb;141(2):343-6. — View Citation

Bayford R, Tizzard A. Bioimpedance imaging: an overview of potential clinical applications. Analyst. 2012 Oct 21;137(20):4635-43. doi: 10.1039/c2an35874c. Review. — View Citation

Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. Review. — View Citation

Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. Epub 2003 Dec 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional Lung Aeration	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.	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Yes
Secondary	Regional Lung Ventilation	Change in Regional Lung Ventilation (difference between end-inspiratory and end-expiratory lung impedance before and post-intervention).	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Yes
Secondary	Heart Rate	Change in Heart Rate (beats per minute).	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Yes
Secondary	Mean Arterial Pressure	Change in Mean Arterial Pressure (mmHg)	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Yes
Secondary	Respiratory Rate	Change in Respiratory Rate (breath per minute)	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Yes
Secondary	Periferic Saturation of Oxygen	Change in Periferic Saturation of Oxygen (fraction of oxygen-saturated hemoglobin relative to total hemoglobin).	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Yes

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