Applicability of Techniques of Lung Expansion

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: EPAP; Other: Breath Stacking

• Registration Number: NCT02613832
• Lead Sponsor: Universidade Federal de Pernambuco

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.

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 Timeline

• Study First Submitted: 2013-10-25
• Study Start: 2014-08
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-22
• Last Update Submitted: 2015-11-22
• Study First Posted: 2015-11-25
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EPAP Group	EPAP	The EPAP devices increase the alveolar pressure. This effect is obtained through valves that generate a resistance to airflow during expiration.
Breath Stacking Group	Breath Stacking	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.

Primary Outcome Measures

Name	Time	Method
Regional Lung Aeration	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

Name	Time	Method
Mean Arterial Pressure	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Change in Mean Arterial Pressure (mmHg)
Respiratory Rate	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Change in Respiratory Rate (breath per minute)
Heart Rate	Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.	Change in Heart Rate (beats per minute).
Periferic Saturation of Oxygen	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).
Regional Lung Ventilation	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).

Trial Locations

Locations (1)

Hospital of Clinics of the Federal University of Pernambuco; 🇧🇷 Recife, PE - Pernambuco, Brazil