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Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age (LC SPRINT Sp)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard nebulizer
PARI LC Sprint Sp nebulizer
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring nebulizer, PARI LC Spring SP

Eligibility Criteria

6 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The parent or legal representative must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria:
  • requires oxygen: SpO2 <92% on room air (if CAS ≤ 4/10)

    • And / or CAS> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care).

Exclusion Criteria:

  • The patient is participating in another study
  • The patients has already been included in this study a previous time
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The parent or legal representative refuses to sign the consent
  • It is impossible to correctly inform the parent or legal representative
  • The patient has a contra indication for a treatement used in this study
  • Patient was born at < 34 weeks of pregnancy or bronchdysplasic
  • First or second episode of bronchiolitis
  • Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive.
  • Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV
  • Patient with known congenital heart disease
  • Patient with chronic respiratory disease other than asthma
  • Patient with encephalopathy
  • Patient with known immune deficiency
  • CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% when asleep for at least 12h

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard nubulizer

Experimental nebulizer

Arm Description

Nebulizer sessions for the patients in this arm will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.

Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

Outcomes

Primary Outcome Measures

Length of hospitalization
The length of hospitalization in days

Secondary Outcome Measures

Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Duration of oxygen therapy
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate before the first nebulisation session
Heart rate before the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
Heart rate 30 minutes after the first nebulisation session
Heart rate 30 minutes after the first nebulisation session (bpm)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
SpO2 saturation less thant 90% during or after nebulisation session?
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Parent estimated tolerance
A visual analog scale is used to evaluate how parents estimate aerosol tolerance.
Length of hospitalization according to discharge criteria
length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score CAS) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep

Full Information

First Posted
July 23, 2012
Last Updated
January 31, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01649401
Brief Title
Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
Acronym
LC SPRINT Sp
Official Title
Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 4, 2016 (Actual)
Study Completion Date
November 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.
Detailed Description
The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp Nebulizer results in: A-shortened duration of oxygen-dependence. B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation <90% during the nebulisation sessions. C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents). D-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
nebulizer, PARI LC Spring SP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard nubulizer
Arm Type
Active Comparator
Arm Description
Nebulizer sessions for the patients in this arm will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
Arm Title
Experimental nebulizer
Arm Type
Experimental
Arm Description
Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany
Intervention Type
Device
Intervention Name(s)
Standard nebulizer
Other Intervention Name(s)
Micro Mist Nebulizer
Intervention Description
Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
Intervention Type
Device
Intervention Name(s)
PARI LC Sprint Sp nebulizer
Intervention Description
Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany
Primary Outcome Measure Information:
Title
Length of hospitalization
Description
The length of hospitalization in days
Time Frame
hospital discharge (maximum of 10 days)
Secondary Outcome Measure Information:
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 0
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 0
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 0
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 0
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 1
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 2
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 3
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 4
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 5
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 6
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 7
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 8
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 9
Title
Duration of oxygen therapy
Description
Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours
Time Frame
Day 10
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 1
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 2
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 3
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 4
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 5
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 6
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 7
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 8
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 9
Title
Heart rate before the first nebulisation session
Description
Heart rate before the first nebulisation session (bpm)
Time Frame
Day 10
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 1
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 2
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 3
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 4
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 5
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 6
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 7
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 8
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 9
Title
Heart rate 30 minutes after the first nebulisation session
Description
Heart rate 30 minutes after the first nebulisation session (bpm)
Time Frame
Day 10
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 1
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 2
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 3
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 4
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 5
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 6
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 7
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 8
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 9
Title
SpO2 saturation less thant 90% during or after nebulisation session?
Description
Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)
Time Frame
Day 10
Title
Parent estimated tolerance
Description
A visual analog scale is used to evaluate how parents estimate aerosol tolerance.
Time Frame
Hospital discharge (maximum 10 days)
Title
Length of hospitalization according to discharge criteria
Description
length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score CAS) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep
Time Frame
Hospital discharge (maximum 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The parent or legal representative must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria: requires oxygen: SpO2 <92% on room air (if CAS ≤ 4/10) And / or CAS> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care). Exclusion Criteria: The patient is participating in another study The patients has already been included in this study a previous time The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The parent or legal representative refuses to sign the consent It is impossible to correctly inform the parent or legal representative The patient has a contra indication for a treatement used in this study Patient was born at < 34 weeks of pregnancy or bronchdysplasic First or second episode of bronchiolitis Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive. Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV Patient with known congenital heart disease Patient with chronic respiratory disease other than asthma Patient with encephalopathy Patient with known immune deficiency CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% when asleep for at least 12h
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucie Gilton-Bott, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

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