NCT03464071

Brief Summary

Due to the failure of the respiratory system, many patients admitted to the Intensive Care Units (ICUs) require the institution of invasive mechanical ventilation (MV), aiming at maintaining gas exchange, reversing respiratory muscle fatigue, among other benefits. However, an artificial airway installation may be harmful because of its deleterious capacity to the mucociliary clearance mechanism, predisposing to the accumulation of secretions and consequent respiratory infections. Physiotherapy in patients critical for the purpose of preventing and treating these respiratory complications. In this way, they are techniques that aim at a reexpansion and removal of airborne secretions. An application of manual hyperinflation with the Ambú (HM), applied through compression of the resuscitator (Ambu), an application of hypertension for the use of energy, pulmonary volume. Similar to the goal of manual hyperinflation, a hyperinflation maneuver without mechanical ventilator (HVM) is also widely used and has been shown to be effective. A maneuvering visa re-expansion of collapsed lung areas and increased peak expiratory flow, resulting in the mobilization of secretions. It is known that these techniques can cause deleterious effects to the lungs due to the high volumes administered and the variation in airway depression, predisposing to barotrauma and volutrauma, increasing the lung permeability and consequent pulmonary edema. There may also be a more subtle form of injury, such as a release of lung mediators, initiating a process of local inflammation. This biological response is called biotrauma, and if these mediators translocate into the systemic circulation, it can lead to dysfunction and death. The aim of the present study was to evaluate the biomarkers of pulmonary lesion in the hyperinflation maneuver with mechanical ventilator versus manual hyperinflation with environments in sudden patients under mechanical ventilation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

March 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

July 31, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

March 7, 2018

Last Update Submit

July 30, 2019

Conditions

Sepsis

Keywords

sepsisbiomarkerslung injury

Outcome Measures

Primary Outcomes (2)

  • Interleukin 8 (IL-8)

    A sample of 4.5 mL of blood from the study participant for analysis of lung injury biomarkers will be collected in an EDTA tube and then analyzed using the Luminex Human Magnetic Assay kit

    variation in 3 hours

  • Receptor for advanced glycation end products (RAGE)

    A sample of 4.5 mL of blood from the study participant for analysis of lung injury biomarkers will be collected in an EDTA tube and then analyzed using the Luminex Human Magnetic Assay kit

    variation in 3 hours

Secondary Outcomes (10)

  • Systolic blood pressure

    variation in 3 hours

  • Diastolic blood pressure

    variation in 3 hours

  • Heart rate

    variation in 3 hours

  • Mean arterial pressure

    variation in 3 hours

  • Respiratory rate

    variation in 3 hours

  • +5 more secondary outcomes

Study Arms (2)

Group HVM

EXPERIMENTAL

When randomized to the Hyperinflation with mechanical ventilator (HVM) group, there will be an increase in initial positive inspiratory pressure until reaching a peak pressure of 40 cmH2O and PEEP equal to 7 cmH2O

Device: Hyperinflation with mechanical ventilator

Group HM

EXPERIMENTAL

When randomized to the Manual hyperinflation (HM) group, the manual resuscitation bag will be connected to the oxygen system at five liters per minute. The participant will be disconnected from the ventilator and then initiate a slow inspiration with inspiratory pause followed by abrupt expiration, totaling twelve (12) cycles / minute.

Device: Manual hyperinflation

Interventions

Hyperinflation with mechanical ventilatorDEVICE

increase in initial positive inspiratory pressure until reaching a peak pressure of 40 cmH2O and PEEP equal to 7 cmH2O

Group HVM
Manual hyperinflationDEVICE

the manual resuscitation bag will be connected to the oxygen system at five liters per minute. The participant will be disconnected from the ventilator and then initiate a slow inspiration with inspiratory pause followed by abrupt expiration, totaling twelve (12) cycles / minute.

Group HM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to the ICPA ICU who have a minimum of 24 hours under mechanical ventilation, coupled to the orotracheal tube (TOT) or tracheostomy (TQT) in pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) .
  • Hemodynamically stable patients with mean arterial pressure equal to or greater than 60 mmHg with Noradrenaline doses of less than 0.5 μg / kg / minute.
  • Septic patients.

You may not qualify if:

  • Patients with contraindications to increased positive pressure (non-drained pneumothorax and hemothorax, subcutaneous emphysema).
  • Patients with a diagnosis of adult respiratory distress syndrome (ARDS).
  • Neurosurgical patients who are under intracranial pressure monitoring (ICP);
  • Patients with Peak inspiratory pressure (PIP) = 40 cmH2O and / or PEEP\> 10 cmH2O.
  • Post-surgical patients
  • Patients submitted to extracorporeal circulation (ECC)
  • Chronic renal patients
  • Patients without relatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

SepsisLung Injury

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Silvia Regina Rios Vieira

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalia Silva de Oliveira

CONTACT

+5551993455913nsdoliveira@hcpa.edu.br

Wagner da Silva Naue

CONTACT

+5551999767688wnaue@hcpa.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 13, 2018

Study Start

March 23, 2018

Primary Completion

September 10, 2019

Study Completion

December 20, 2019

Last Updated

July 31, 2019

Record last verified: 2019-03

Locations

BR(1)