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StrokeNCT02613832

Applicability of Techniques of Lung Expansion

A study testing EPAP and Breath Stacking in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
EPAP and Breath Stacking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBrazil
Study dates
Aug 2014to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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%).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital of Clinics of the Federal University of Pernambuco

    Recife, PE - Pernambuco, 50670330

Other trials in Brazil

About this study

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

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.

Read the 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
Being tested
EPAP, Breath Stacking
Keywords
Noncooperative patients
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPAPOther

    Also called Expiratory Positive Airway Pressure

    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 StackingOther

    Also called Air 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.

Study groups in NCT02613832
Study groupRoleWhat they receive
EPAP GroupExperimentalThe EPAP devices increase the alveolar pressure. This effect is obtained through valves that generate a resistance to airflow during expiration.
Receives: Other: EPAP
Breath Stacking GroupExperimentalThe 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.
Receives: Other: Breath Stacking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

Secondary outcomes (5)

  1. Regional Lung Ventilation

    Change in Regional Lung Ventilation (difference between end-inspiratory and end-expiratory lung impedance before and post-intervention).

    Measured: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

  2. Heart Rate

    Change in Heart Rate (beats per minute).

    Measured: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

  3. Mean Arterial Pressure

    Change in Mean Arterial Pressure (mmHg)

    Measured: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

  4. Respiratory Rate

    Change in Respiratory Rate (breath per minute)

    Measured: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

  5. Periferic Saturation of Oxygen

    Change in Periferic Saturation of Oxygen (fraction of oxygen-saturated hemoglobin relative to total hemoglobin).

    Measured: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613832
Sponsor's protocol ID
Caio01
Status last verified
Nov 2015
First submitted
25 Oct 2013
Last updated
25 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

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

    PubMed 22930423

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

    PubMed 19186406

  • 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.

    PubMed 14693669

  • 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.

    PubMed 2301851

  • 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.

    PubMed 33024002

Questions about this trial

What is this clinical trial studying?

A study testing EPAP and Breath Stacking in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional Lung Aeration (time frame: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613832, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.

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