Point of Care Ultrasound in Pregnant Women (PoCUS-OB)

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for pregnant women past 20 weeks who have untreated sleep apnea found recently, or a high chance of it. An ultrasound of the airway is compared with a home sleep test.

Életkor

18 years or older

Nem

Women only (pregnant)

A betegség stádiuma

More than 20 weeks of pregnancy. ASA physical status I - IV (a scale of general health before anaesthesia). Obstructive sleep apnea found in the past 12 months and not treated, or a high chance of it (score ≥ 75 on the Facco et al. scale).

Korábbi kezelés

Sleep apnea must not have been treated. People using CPAP (a breathing machine used at night) cannot join.

A részvétel fő kizáró okai

• Past surgery of the mouth, head or neck, such as surgery for sleep apnea
• Active head or neck disease, such as cancer, infection or radiotherapy
• Not able to do the home sleep test as instructed
• Diagnosed sleep apnea already treated with CPAP

Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: * Pregnant women ≥ 18 years of age

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Pregnant women with gestational age more than 20 weeks are at risk of developing Obstructive Sleep Apnea (OSA). OSA is a common underdiagnosed comorbid condition in pregnant women associated with adverse maternal and fetal outcomes. It is a severe form of sleep-disordered breathing (SDB), featured with repeated episodes of airflow reduction or cessation during sleep. It exists in different severity among pregnant women and maybe worsen over the course of the pregnancy. If OSA remains untreated, it can complicate the pregnancy by developing heart failure, gestational diabetes, pre-eclampsia, eclampsia, and hypertension. To determine the OSA during pregnancy has become an important issue to reduce the morbidity related to it. Currently, Polysomnography (PSG) remains the gold standard for diagnosing OSA, but scheduling and logistics remain significant impediments to accessibility for pregnant women. Home sleep apnea tests (HST) is a promising alternative but are expensive and not widely available. Point of care ultrasonography (PoCUS) is being increasingly used across specialties. Our preliminary data support the feasibility of PoCUS in the preoperative setting and increasing the diagnostic accuracy and the specificity for moderate to severe OSA (AHI >15 events per h) when combined with the STOP-Bang questionnaire (cut-off >5). Given that HST shows high levels of agreement with PSG for the diagnosis of OSA and are significantly less burdensome than PSG, investigators will evaluate the PoCUS airway examination against the HST for the diagnosis of OSA in pregnant women at high risk of OSA.

A vizsgált kezelések

• PoCUS