Anti-inflammatory Effect of Nocturnal NIPPV on Acute Asthma

August 22, 2019 updated by: Jose Luis Carrillo Alduenda, National Institute of Respiratory Diseases, Mexico

National Institute of Respiratory Diseases Mexico

INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical ventilation to the airway through non-invasive positive pressure ventilation (NIPPV) decreases bronchial hyperreactivity and contractility of smooth muscle.

OBJECTIVES: To assess the effect of nocturnal NIPPV on local inflammation, systemic inflammation and the state of hypersensitivity in patients with asthma attack.

MATERIALS AND METHODS: We will include patients with severe asthma attacks requiring hospitalization, without indication for acute NIPPV, and will be randomized to receive NIPPV with an spontaneous (S) bilevel or continuous positive airway pressure (CPAP, control group), all patients will receive standard treatment; gasometric exchange, local inflammation (FEV1 and Exhaled fraction of nitric oxide), systemic inflammation (C reactive protein, IL-4, IL-5, IL-13 and IL-17 in peripheral blood) and the hypersensitivity state (eosinophilia and IgE) between both groups will be compared after 4 days of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RESEARCH QUESTION What is the effect of non invasive positive pressure ventilation (NIPPV) on systemic inflammation in patients with asthma attacks?

JUSTIFICATION Asthma is a global public health problem and one of the primary causes of care at the National Institute of Respiratory Diseases in Mexico; when presented as a crisis is a serious condition that puts the life of the patient at risk; in vitro and in vivo studies have shown that the application of chronic airway distention using non-invasive mechanical ventilation produces a reduction in bronchial hyperreactivity in patients with asthma and may have a positive effect on the treatment of this condition independent of its effects on ventilation in the presence of acute respiratory failure.

HYPOTHESIS The use of NIPPV will improve systemic inflammation assessed by C reactive protein (CRP) in patients with severe asthmatic crisis.

OBJECTIVES

Main Objective:

To assess the effect of NIPPV on systemic inflammation measure through C reactive protein in acute asthma

Secondary objectives:

  1. - To assess the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
  2. - To evaluate adherence to NIPPV in patients with asthma attacks.
  3. - To evaluate the effect of NIPPV on PaO2, PaCO2 and SpO2 in patients with asthma attacks.
  4. - To evaluate the effect of NIPPV on FEV1 and Exhaled fraction of nitric oxide in patients with asthma attacks.
  5. - To evaluate the effect of NIPPV on serum levels of interleukin (IL)-4, IL-5, IL-13 and IL-17 in patients with asthma attacks.
  6. - To assess the effect of NIPPV on total eosinophil count and Immunoglobulin (Ig) E level in patients with asthma attacks.

MATERIALS AND METHODS

  1. Design: A prospective, longitudinal, comparative, parallel group study will be conducted; it was approved by the Science and Bioethics Committees of the National Institute of Respiratory Diseases Mexico with the code C34-14. In all cases, informed consent will be requested.
  2. Place: It will be carried out in the emergency and hospitalization service of the National Institute of Respiratory Diseases "Ismael Cosío Villegas" at Mexico city.

  3. - Procedures:

    • Clinical history.
    • Chest X-ray.
    • Berlin Questionnaire. The Berlin questionnaire is a self-administered questionnaire validated in Spanish to establish the risk of obstructive sleep apnea.
    • Arterial gasometry.
    • Blood cell count.
    • Ultrasensitive C-reactive protein.
    • Determination of IgE.
    • Spirometry and Exhaled fraction of nitric oxide according to international guidelines.

  4. - Intervention: Patients included will be randomized to receive, 4 nights of noninvasive nocturnal positive pressure ventilation with an S Bilevel device with a 12 cmH2O inspiratory pressure and a 4 cmH2O expiratory pressure or a 4 cmH2O Continuous Positive Airway Pressure (CPAP), as a control group.

    The equipment will be placed at night ad libitum and retired the following day in the morning, in all cases a VPAP ST S8 RESMED will be used. If the patient needs to increase inspired oxygen fraction it will be performed with nasal tips during the day and a distal oxygen connector at night. In all cases a nasal mask will be used.

    Blood gasometry, blood cell count, CRP, serum IL-4, IL-5, IL-13, IL-17 and IgE, Spirometry and Exhaled fraction of nitric oxide will be repeated at day 4.

  5. - Data Analysis A convenience sample of 20 patients was established. A balanced randomization will be performed. The variables were summarized according to their type and distribution. The comparison of dichotomous variables will be performed using Fisher's Exact test. The comparison of independent continuous variables will be carried out with U of Mann Whitney and the related variables will be analyzed with Wilcoxon Related Ranks Test.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de México, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of asthma, performed by a physician, with spirometry and stable treatment for at least 3 previous months.
  • Severe asthma crisis and hospitalization requirement of at least 4 days.

Exclusion Criteria:

  • Life-threatening crisis.
  • Requirement of Invasive or Non-Invasive Mechanical Ventilation.
  • High risk for Obstructive Sleep Apnea (measured through the Berlin questionnaire).
  • Active smoking.
  • Another chronic lung disease other than asthma.
  • Pneumonia (defined by the presence of an opacity of the lung parenchyma on a chest x-ray).
  • Ischemic heart disease.
  • Uncontrolled systemic arterial hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIPPV
Patients will receive NIPPV with an S bilevel device during 4 nights, the equipment will be placed ad libitum, a 12 cmH2O inspiratory pressure and a 4 cmH2O expiratory pressure will be administered through a nasal mask. CRP, FEV1, exhaled fraction of nitric oxide, IL-4, IL-5, IL-13, IL-17, IgE, cell count will be measured before and after intervention.
Device: NIPPV
Application of chronic distension of the airway through NIPPV to produce a reduction in bronchial hyperreactivity.
Other Names:
  • bilevel
Sham Comparator: CPAP
Patients will receive a 4 cmH2O continuous positive airway pressure device during 4 nights; this is the minimum pressure necessary to avoid death space with no effect on minute ventilation. The equipment will be placed ad libitum. Pressure will be administered through a nasal mask. CRP, FEV1, exhaled fraction of nitric oxide, IL-4, IL-5, IL-13, IL-17, IgE, cell count will be measured before and after sham intervention.
Device: CPAP
4 cmH2O CPAP as the minimum pressure necessary to mobilize the air flow and avoid the space death with no effect on the ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic Inflammation
Time Frame: 4 days
To evaluate the effect of NIPPV on C reactive protein in patients with asthma attacks.
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: 4 days
To evaluate the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
4 days
Adherence
Time Frame: 4 days
To evaluate adherence to NIPPV in patients with asthma attacks
4 days
Gas Exchange
Time Frame: 4 days
To evaluate the effect of NIPPV on PaCO2, PaO2 and SaO2 in patients with asthma attacks.
4 days
Local Inflammation
Time Frame: 4 days
To evaluate the effect of NIPPV on FEV1 and exhaled fraction of nitric oxide in patients with asthma attacks.
4 days
Serum Inflammation
Time Frame: 4 days.
To evaluate the effect of NIPPV on serum IL-4, IL-5, IL-13 e IL-17 in patients with asthma.attacks.
4 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Principal Investigator: Jose Luis Carrillo Alduenda, Instituto Nacional de Enfermedades Respiratorias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C34-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through this organization and will be provided at the individual request of each interested researcher.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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