NCT02613832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

October 25, 2013

Last Update Submit

November 22, 2015

Conditions

Stroke

Keywords

Noncooperative patients

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Regional Lung Ventilation

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

  • Heart Rate

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

  • Mean Arterial Pressure

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

  • Respiratory Rate

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

  • Periferic Saturation of Oxygen

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

Study Arms (2)

EPAP Group

EXPERIMENTAL

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

Other: EPAP

Breath Stacking Group

EXPERIMENTAL

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.

Other: Breath Stacking

Interventions

EPAPOTHER

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.

Also known as: Expiratory Positive Airway Pressure
EPAP Group
Breath StackingOTHER

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.

Also known as: Air Stacking
Breath Stacking Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Clinics of the Federal University of Pernambuco

Recife, PE - Pernambuco, 50670330, Brazil

Location

Related Publications (5)

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

    PMID: 22930423BACKGROUND

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

    PMID: 19186406BACKGROUND

  • 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.

    PMID: 14693669BACKGROUND

  • 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.

    PMID: 2301851BACKGROUND

  • 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.

    PMID: 33024002DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Caio César A Morais, Master

    Universidade Federal de Pernambuco

    STUDY CHAIR

  • Shirley L Campos, PHD

    Universidade Federal de Pernambuco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in cardiopulmonary physiotherapy

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 25, 2015

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations

BR(1)