Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .

Sickle Cell Disease Clinical Trial

— SPIDO  

Official title:

Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: Impact on the Length of Stay. Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041180
• Other study ID #: CHRO-2018-04
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: April 6, 2019

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 6, 2019
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Pediatric
• Sickle Cell Disease

Locations

Country	Name	City	State
France	CHR d'Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of day staying in the pediatric ward according to the maximal inspiratory capacities during incentive spirometry sessions.		throught study completion, an overage of 24hours
Secondary	Correlation between pain level and maximal inspiratory capacity during incentive spirometry sessions.		throught study completion, an overage of 24hours
Secondary	Correlation between the maximum inspiratory volume achieved during incentive spirometry and children's mobility (attitude and mobility items according to the EVENDOL scale).		throught study completion, an overage of 24hours
Secondary	Correlation between the use of analgesic strategies and the inspiratory volume related to patients' size and age		throught study completion, an overage of 24hours

External Links

•   French guidelines for the management of adult sickle cell disease: 2015 update
•   Management of Sickle Cell Disease Summary of the 2014 Evidence-Based Report by Expert Panel Members
•   Positive Expiratory Pressure Device Acceptance by Hospitalized Children With Sickle Cell Disease Is Comparable to Incentive Spirometry