Influence of Mechanical Ventilation Modes on the Efficacy of Nebulized Bronchodilator

NCT03271905 | Unknown DMC

• 1 other identifier: CibelleAndrade
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Aerosol therapy is widely used in intensive care in critically ill patients that use mechanical ventilation (MV). However, there is a lack of standardization about aerosol performance in this group of patients. Thus, this study aims to evaluate the effect of nebulization performed in different ventilatory modes on lung function and regional pulmonary distribution of critical patients with chronic obstructive pulmonary disease. It is a clinical trial, crossover, randomized, controlled and blind. Three interventions with bronchodilators will be performed: in the Pressure Controlled Ventilation mode (PCV) with positive end expiratory pressure (PEEP) = 85% of autoPEEP, in the PCV mode with PEEP = 15 cmH2Oand in the Pressure Support Mode (PSV). Pulmonary function data will be evaluated through Electrical Impedance Tomography to evaluate the efficacy of the bronchodilator in different ventilatory modes.

Conditions

COPD; Asthma

Outcome Measures

Primary Outcomes (1)

• Change in tidal Impedance Variation

  compare regional ventilation distribution by electrical impedance tomography

  change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator

Secondary Outcomes (3)

• Change in compliance of respiratory sistem (cmH2O)

  change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator

• Change in peak expiratory flow (lpm)

  change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator

• Change in End-Expiratory Lung Volume

  change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator

Study Arms (3)

Pressure-controled-ventilation (PCV)

EXPERIMENTAL

Nebulization during mechanical ventilation on a pressure controled ventilation mode.

Drug: salbutamol sulfate and ipratropium bromide; Device: Mesh nebulization

PCV and high PEEP

EXPERIMENTAL

Nebulization during mechanical ventilation on a pressure controled ventilation mode and PEEP = 15 cmH2O.

Drug: salbutamol sulfate and ipratropium bromide; Device: Mesh nebulization

Pressure suport ventilation (PSV)

EXPERIMENTAL

Nebulization during mechanical ventilation on a pressure suport ventilation mode.

Drug: salbutamol sulfate and ipratropium bromide; Device: Mesh nebulization

Interventions

salbutamol sulfate and ipratropium bromide DRUG

Nebulization with salbutamol sulfate and ipratropium bromide during mechanical ventilation.

PCV and high PEEP; Pressure suport ventilation (PSV); Pressure-controled-ventilation (PCV)

Mesh nebulization DEVICE

Nebulization with Mesh device.

PCV and high PEEP; Pressure suport ventilation (PSV); Pressure-controled-ventilation (PCV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with asthma or chronic obstructive pulmonary disease (COPD) Invasive mechanical ventilation Hemodynamically stable

You may not qualify if:

• Prescribed metered dose inhaler (MDI) or intravenous bronchodilators Undrained pneumothorax Bronchopleural fistula Chest trauma Tracheoesophageal fistula Tracheal granulomas Tracheal stenosis PEEP dependence
• Contraindicated disconnection of the MV
• Endotracheal tube diameter less than 7.5
• Do not make part of the protocol of daily sedation
• No regular ventilatory drive when with out sedation
• Do not reach a minimum tidal volume 6 ml/kg with a maximum peak pressure (PIP) of 35 cmH2O (centimeter of water) during MV.
• Do not use the same MV modes that will be tested in this study

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Cibelle Andrade Lima

Recife, Pernambuco, 50610060, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant is blind about the procedures. The investigator is blind about order of procedure and outcomes assessor is blind about procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: September 5, 2017
• Study Start: April 10, 2017
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)