This study will investigate the feasibility of a hypoxic challaenge test (60 minutes duration). During this test the inspired air will have a oxygen content of 15%. This is a comparable value as is used during a commercial airline flight (ca 2500…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to investigate the feasibility of a hypoxic
challange test (HCT) in children with congenital heart of lung disease. This
HCT was previously developped and use in healthy children (Kobbernagel et al
2013). Feasibility is defined as succesful run through of the measurements in
75% of the subjects.
Secondary outcome
The secondary aim is to monitor the oxygen saturation during each of the
activities using a pulse oxymeter (index finger) and a tissue saturation
monitor (NIRS) on the forehead and leg. (m. vasus lateratus). These values will
be compared to the values obtained breating regular (sea level) air (21%
oxygen).
Background summary
Children with a congenital heart and lung disease have a reduced function of
the oxygen transport system from lung to muscle and organs. During a stay at
altitude or during an airline flight, the barometric pressure is reduced and
hence the partial pressure for oxygen. This could further impde the functioning
of the oxygen transport system.
Study objective
This study will investigate the feasibility of a hypoxic challaenge test (60
minutes duration). During this test the inspired air will have a oxygen content
of 15%. This is a comparable value as is used during a commercial airline
flight (ca 2500 meter, oxygen % 15%). Furthermore, we will investigate the
oxygen saturation as well as the tissue saturation in blood and muscle of the
subjects.
Study design
This is an observational pilot study with non-invasive measurements.
Subjects will be equipped with a face mask. This mask will be connected to a
altitude simulator (Hypoxico Hypoxic generator) dat will simulate an altitude
of 2500 meter. The simulator generates air with an oxygen content of 15%.
A pulse oxygen saturation meter will be attached to in index finger of a
subject, and a NIRS probe will be attached to the forehead and leg.
The measurements will be performed during a standardized hypoxic challange test
(HCT). The HCT consists of alternating, non-randomised periods of breathing
room air (10 minutes) followed by a period at a simulated altitude of 2500
above sea level. During this period the patients will be monitored, while
sitting and watching a DVD (15 min), laying supine (10 min) and standing (5
min) and while walking on a treadmill at 3 km/h (5 min) and at 5 km/h (5 min).
All measurements will be performed at the Child Development & Exercise Center
by an exercise physiologist of the Wilhelmina Children's Hospital.
Study burden and risks
The burden and risks are estimated to be minimal.
Grouprelatedness: Children have a unique physiological response to exercise,
which develops with growth and developments. This response is differnt compared
to adults. In addition, exercise responses (ventilation and circulation) are
different in children with heart or lung disease compared to healthy children.
Therefore, this study can only be conducted in this patient population.
Lundlaan 6
Utrecht 3508 EA
NL
Lundlaan 6
Utrecht 3508 EA
NL
Listed location countries
Age
Inclusion criteria
Children with congenital heart or lung diseae
Age between 8 and 21 years of age
Able to walk (walking on treadmill)
Exclusion criteria
Lungfunction (FEV1) below 70% of predicted or oxygen saturation in rest <90%.
Design
Recruitment
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 | NL50104.041.14 |