Skip to main content
OpenTrials
Completed

NCT Number: NCT02613832

Applicability of Techniques of Lung Expansion

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Clinics of the Federal University of Pernambuco

Recife, PE - Pernambuco, 50670330, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Presence of chronic lung diseases;
  • Chest deformity;
  • Rib fracture;
  • Asymmetrical chest expansion;
  • Abdomen distension;
  • Spasticity in any hemisphere with Ashworth Scale score more than 2 points for upper limbs;
  • Uncoordinated movements of the limbs;
  • Cardiorespiratory instability (heart rate < 60 or > 120 bpm; respiratory rate > 35 ipm; mean arterial pressure < 60 mmHg or > 120 mmHg; oxygen saturation < 90%).

Treatment and study plan

EPAP

Other

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 names: Expiratory Positive Airway Pressure

Breath Stacking

Other

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 names: Air Stacking

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Nov 25, 2015
Registry last updated
Nov 25, 2015

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.

Published trials that share one or more normalized conditions with this study.