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

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649401
• Other study ID #: LOCAL/2012/LG-02
• Secondary ID: 2012-A00629-34
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: January 31, 2017
• Start date: December 2012
• Est. completion date: November 4, 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 4, 2016
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Standard nebulizer
Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
• PARI LC Sprint Sp nebulizer
Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization	The length of hospitalization in days	hospital discharge (maximum of 10 days)
Secondary	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	Day 0
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 0
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 0
Secondary	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)	Day 0
Secondary	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	Day 1
Secondary	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	Day 2
Secondary	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	Day 3
Secondary	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	Day 4
Secondary	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	Day 5
Secondary	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	Day 6
Secondary	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	Day 7
Secondary	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	Day 8
Secondary	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	Day 9
Secondary	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	Day 10
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 1
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 2
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 3
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 4
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 5
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 6
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 7
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 8
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 9
Secondary	Heart rate before the first nebulisation session	Heart rate before the first nebulisation session (bpm)	Day 10
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 1
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 2
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 3
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 4
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 5
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 6
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 7
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 8
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 9
Secondary	Heart rate 30 minutes after the first nebulisation session	Heart rate 30 minutes after the first nebulisation session (bpm)	Day 10
Secondary	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)	Day 1
Secondary	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)	Day 2
Secondary	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)	Day 3
Secondary	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)	Day 4
Secondary	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)	Day 5
Secondary	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)	Day 6
Secondary	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)	Day 7
Secondary	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)	Day 8
Secondary	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)	Day 9
Secondary	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)	Day 10
Secondary	Parent estimated tolerance	A visual analog scale is used to evaluate how parents estimate aerosol tolerance.	Hospital discharge (maximum 10 days)
Secondary	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	Hospital discharge (maximum 10 days)