Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04828408 |
Other study ID # |
2019/02-16.derya |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2019 |
Est. completion date |
September 2, 2019 |
Study information
Verified date |
March 2021 |
Source |
Turkiye Yuksek Ihtisas Education and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Obesity is an important public health problem all over the world, and its prevalence is
increasing every year. In obesity, significant changes occur in the mechanical properties of
the lungs and chest wall due to fat deposits in the mediastinum and abdominal cavities. Upper
abdominal surgical procedures usually cause impairment of respiratory functions by affecting
respiratory volume and capacity. The risk of postoperative pulmonary complications increases
with the decrease in restrictive capacities, hypoxemia, and increased respiratory work. It
may also be due to causes such as diaphragm dysfunction, postoperative pain, and surgical
incision.Ultrasonography (USG) is a method accepted for evaluating the normal and
pathological conditions of the diaphragm. M-mode is used to evaluate the anatomical and
functional disorders of the diaphragm. The diaphragm evaluation is performed with the
anterior approach in the supine position and with different respiratory maneuvers (sniffing,
deep inspiration, normal inspiration).
The aim of the study was to evaluate the diaphragm function by using USG and spirometry
methods in patients who underwent bariatric surgery and to investigate the effect of
postoperative pain score on diaphragm function.
Description:
Approval for this single-center, prospective, observational study was performed after the
approval of the local Ethics Committee and informed consent from the patients.
Diaphragm ultrasonography was performed before general anesthesia, after general anesthesia
in the recovery room, and at the postoperative 24th hour in normal breathing, deep
inspiration, and sniffing position. For USG evaluation, while the patients sit in the supine
position at an angle of 45⁰, the 2.5-7.5 Mhz convex probe is placed perpendicular to the
intercostal spaces through the liver window on the anterior axillary line; The posterior part
of the right hemidiaphragm was evaluated by directing it medially, cephalad and dorsally.
Diaphragm movements in M-mode were evaluated after detection of the diaphragm in the B-mode.
The inspiratory amplitude of the diaphragm (DIA: distance traveled by the diaphragm between
the beginning and end of inspiration, cm) in M-mode, inspiratory velocity (IV=
DIA/inspiratory time, cm/sec), and expiratory velocity (EV= DIA/expiratory time, cm/sec)
measurements were made. VAS scores of the patients were questioned while performing USG.
Pulmonary function tests (PFT) of patients before surgery and the postoperative first day and
FVC, FEV1, PEF, FEF25-75, and FEV1/FVC measurements have been recorded.