Applicability of Techniques of Lung Expansion

NCT ID: NCT02613832

Last Updated: 2015-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EPAP Group

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

Group Type: EXPERIMENTAL

EPAP

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Breath Stacking

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Expiratory Positive Airway Pressure; Air Stacking

Eligibility 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%).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Caio César Araújo Morais

Specialist in cardiopulmonary physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caio César A Morais, Master

Role: STUDY_CHAIR

Universidade Federal de Pernambuco

Shirley L Campos, PHD

Role: STUDY_CHAIR

Universidade Federal de Pernambuco

Locations

Hospital of Clinics of the Federal University of Pernambuco

Recife, PE - Pernambuco, Brazil

Countries

Brazil

References

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

Reference Type: BACKGROUND

PMID: 22930423 (View on PubMed)

Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

Reference Type: BACKGROUND

PMID: 19186406 (View on PubMed)

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. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.

Reference Type: BACKGROUND

PMID: 14693669 (View on PubMed)

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. doi: 10.1164/ajrccm/141.2.343.

Reference Type: BACKGROUND

PMID: 2301851 (View on PubMed)

Morais CC, Campos SL, Lima CS, Monte LJ, Bandeira MCP, Brandao DC, Costa EL, Aliverti A, Amato MB, Andrade AD. Acute Effects of Lung Expansion Maneuvers in Comatose Subjects With Prolonged Bed Rest. Respir Care. 2021 Feb;66(2):240-247. doi: 10.4187/respcare.07535. Epub 2020 Oct 6.

Reference Type: DERIVED

PMID: 33024002 (View on PubMed)

Other Identifiers

Caio01

Identifier Type: -

Identifier Source: org_study_id