To evaluate the efficacy of incentive spirometry on the incidence of ACS in adult sickle cell patients admitted with a vaso-occlusive painful crisis.
ID
Source
Brief title
Condition
- Haemoglobinopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To evaluate the efficacy of incentive spirometry in primary prevention of
ACS in adult sickle cell patients during painful crisis.
Secondary outcome
1. To relate the efficacy of incentive spirometry to plasma levels of
phospholipase A2 and serum levels of procalcitonine.
2. To evaluate whether plasma sPLA2 levels may be helpful to stratify patients
in high and low risk groups and to evaluate the value of incentive spirometry
in these groups to prevent ACS.
3. To evaluate whether serum procalcitonine may stratify patients with an ACS
related to an infectious and non-infectious pathogenesis and to evaluate the
value of incentive spirometry to prevent ACS.
4. To identify the micro bacterial organisms responsible for the development of
an acute chest syndrome and to relate this with the procalcitonin plasma
levels.
Background summary
One of the most severe complications during vaso-occlusive painful crisis is
the acute chest syndrome (ACS), ACS is defined as the presence of a new
pulmonary infiltrate (on chest X-ray) in combination with clinical symptoms
such as fever or respiratory symptoms in a patient with SCD. Incentive
spirometry has been demonstrated to be effective as primary prevention of the
development of ACS in children admitted with a vaso-occlusive painful crisis.
However, the effect of incentive spirometry in prevention of ACS in adult
sickle cell patients during painful crisis has not been studied so far.
Therefore, the aim of our study is to evaluate the efficacy of incentive
spirometry on the incidence of ACS in adult sickle cell patients admitted with
a vaso-occlusive painful crisis.
Study objective
To evaluate the efficacy of incentive spirometry on the incidence of ACS in
adult sickle cell patients admitted with a vaso-occlusive painful crisis.
Study design
A multicentre randomized controlled clinical trial, studying the effect of
incentive spirometry on the incidence of ACS in comparison with standard care
in adult sickle cell patients admitted with a vaso-occlusive painful crisis.
Intervention
Patients in the study group will be educated in the use of the spirometer
(Respiflo*FS, Kendall) and the study protocol by the investigator. During
admission patients have to inhale10 times through the spirometer every 2 hours
(between 8 a.m. and 10 p.m.) until at least 24 hours after the pain has
subsided. If awake, patients may use the spirometry also between 10 p.m. and 8
a.m. Patients are asked to register every time they inhale through the
spirometer and pain scores will be assessed (Visual Analog Scores).
Study burden and risks
na
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
High performance liquid chromatography confirmed diagnosis of HbSS, HbSC, HbSB0- or HbSB+-thalassemia genotypes.
Written informed consent by the patient.
Thoracic or back pain above the diaphragm.
Hospital admission due to vaso-occlusive painful crisis.
Exclusion criteria
Blood transfusion in the preceding three months
Diagnosis of Acute Chest Syndrome at presentation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31253.018.10 |