Sickle Cell DiseaseSPIDONCT04041180
Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .
An observational study of Sickle Cell Disease and Pediatric, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
In this prospective observational study among sickle cell children aged 7 to 17 years, who face many experience of pain, pain will be assessed during incentive spirometry sessions. Then a relation between, inspiratory volume, pain and the length of hospital stay will be identified . Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Sickle Cell Disease, Pediatric
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2018to 6 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: sickle cell children admitted to the paediatric department at the CHR of Orléans
Who may be able to join
- Sickle cell children aged 7 to 17 admitted to the pediatric ward
- Children receiving respiratory physiotherapy sessions under medical prescription
- Children hospitalized for more than 24 hours at the CHRO and benefiting from more than one physiotherapy session.
- Absence of opposition of one of the parents to the participation of their child in the study
- Absence of opposition of children able to understand the study
- Non inclusion Criteria:
Show all 10Show fewer
- Sickle cell children under the age of 7 or over 17
- Children with mental deficits
- Non-French-speaking parents
- Children receiving only one physiotherapy session and being hospitalized within 24 hours
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: Impact on the Length of Stay. Prospective Observational Study
In this prospective observational study among sickle cell children aged 7 to 17 years, who face many experience of pain, pain will be assessed during incentive spirometry sessions. Then a relation between, inspiratory volume, pain and the length of hospital stay will be identified .
Currently, there is no scientific data regarding the correlation between acute pain during vaso-occlusive crisis, incentive spirometry and the impact on length of hospital stay. In fact, physiotherapist experience's in the pediatric department suggests that the pain expressed by the child is not always correlated with inspiratory capacity.
Read more
The absence of pain is one of the reasons for hospital discharge after decompensation in patients with sickle cell disease. However, no scientific study has linked incentive spirometry, pain and length of hospital stay.
Investigator assume that these children underestimate the real pain and its impact on breathing pattern, and presume that the maximal inspiratory volume during spirometry sessions will be a better reflect of pain than standard pain scale.
The aim of this study is to show that inspiratory volume would be a better indicator of discharge from hospitalization than actual pain scales.
- Conditions
- Sickle Cell Disease, Pediatric
- Keywords
- Sickle cell disease, incentive spirometry, pain, children
- Medical subject headings
- Anemia, Sickle Cell, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of day staying in the pediatric ward according to the maximal inspiratory capacities during incentive spirometry sessions.
Measured: throught study completion, an overage of 24hours
Secondary outcomes (3)
Correlation between pain level and maximal inspiratory capacity during incentive spirometry sessions.
Measured: throught study completion, an overage of 24hours
Correlation between the maximum inspiratory volume achieved during incentive spirometry and children's mobility (attitude and mobility items according to the EVENDOL scale).
Measured: throught study completion, an overage of 24hours
Correlation between the use of analgesic strategies and the inspiratory volume related to patients' size and age
Measured: throught study completion, an overage of 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start6 Nov 2018
- Primary completion6 Apr 2019
- Study completion6 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Sandrine PELLETIER, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041180
- Sponsor's protocol ID
- CHRO-2018-04
- Acronym
- SPIDO
- Status last verified
- Jul 2019
- First submitted
- 4 Feb 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellet PS, Kalinyak KA, Shukla R, Gelfand MJ, Rucknagel DL. Incentive spirometry to prevent acute pulmonary complications in sickle cell diseases. N Engl J Med. 1995 Sep 14;333(11):699-703. doi: 10.1056/NEJM199509143331104.
PubMed 7637747
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: Impact on the Length of Stay. Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04041180
- Acronym / sponsor ID
- SPIDO / CHRO-2018-04
- Conditions
- Sickle Cell Disease, Pediatric
- Keywords
- Sickle cell disease, incentive spirometry, pain, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 6 Apr 2019 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective observational study among sickle cell children aged 7 to 17 years, who face many experience of pain, pain will be assessed during incentive spirometry sessions. Then a relation between, inspiratory volume, pain and the length of hospital stay will be identified .
Currently, there is no scientific data regarding the correlation between acute pain during vaso-occlusive crisis, incentive spirometry and the impact on length of hospital stay. In fact, physiotherapist experience's in the pediatric department suggests that the pain expressed by the child is not always correlated with inspiratory capacity.
The absence of pain is one of the reasons for hospital discharge after decompensation in patients with sickle cell disease. However, no scientific study has linked incentive spirometry, pain and length of hospital stay.
Investigator assume that these children underestimate the real pain and its impact on breathing pattern, and presume that the maximal inspiratory volume during spirometry sessions will be a better reflect of pain than standard pain scale.
The aim of this study is to show that inspiratory volume would be a better indicator of discharge from hospitalization than actual pain scales.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- sickle cell children admitted to the paediatric department at the CHR of Orléans
Key inclusion criteria (10 listed)
- Sickle cell children aged 7 to 17 admitted to the pediatric ward
- Children receiving respiratory physiotherapy sessions under medical prescription
- Children hospitalized for more than 24 hours at the CHRO and benefiting from more than one physiotherapy session.
- Absence of opposition of one of the parents to the participation of their child in the study
- Absence of opposition of children able to understand the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of day staying in the pediatric ward according to the maximal inspiratory capacities during incentive spirometry sessions.
Time frame: throught study completion, an overage of 24hours
3 secondary outcomes
Correlation between pain level and maximal inspiratory capacity during incentive spirometry sessions.
Time frame: throught study completion, an overage of 24hours
Correlation between the maximum inspiratory volume achieved during incentive spirometry and children's mobility (attitude and mobility items according to the EVENDOL scale).
Time frame: throught study completion, an overage of 24hours
Correlation between the use of analgesic strategies and the inspiratory volume related to patients' size and age
Time frame: throught study completion, an overage of 24hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Results publication: PubMed 7637747Bellet PS, Kalinyak KA, Shukla R, Gelfand MJ, Rucknagel DL. Incentive spirometry to prevent acute pulmonary complications in sickle cell diseases. N Engl J Med. 1995 Sep 14;333(11):699-703. doi: 10.1056/NEJM199509143331104.
- French guidelines for the management of adult sickle cell disease: 2015 updateLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Sandrine PELLETIER principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Pediatric, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of day staying in the pediatric ward according to the maximal inspiratory capacities during incentive spirometry sessions. (time frame: throught study completion, an overage of 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.