Perioperative Apnea, Hypoxemia, and Respiratory Complications
Conditions
Interventions
Trial 1 control:Patients in the control group wore a sleep wristband before going to sleep the day before the operation and removed it after getting up in the morning.
Trial 1 MAPD:The patients in the MAPD group wore a MAPD and a sleep bracelet customized for them in advance before going to sleep the day before the operation, and removed them after getting up in the
Trial 2 control:No special intervention.
Trial 2 MAPD:Patients in the experimental group wore a personalised MAPD before anaesthesia, and the degree of mandibular advancement was adjusted under the guidance of the anaesthetist. The MAPD was
Trial 3 control:No special intervention.
Trial 3 MAPD:Patients in the experimental group wore a custom-made MAPD before anaesthesia, adjusted the mandibular advancement under the guidance of the anaesthetist, and removed the MAPD after the s
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria (1)Age: 18–80 years; (2)Provision of written informed consent; (3)Ability to tolerate oral devices and absence of severe psychiatric disorders. Specific Inclusion Criteria (Hypertension + OSA) (1)Previously diagnosed hypertension, defined by a history of antihypertensive medication use or documented blood pressure control; (2)Suspected or confirmed obstructive sleep apnea (OSA) prior to surgery, defined as: prior polysomnography or portable sleep monitoring showing an apnea–hypopnea index (AHI) >= 5 events/hour, orpreoperative evaluation indicating nocturnal hypoxemia and/or apnea events; (3)Scheduled for elective surgery. Trial 2 (Painless Colonoscopy in Obese Patients) Specific Inclusion: (1) BMI >= 30 kg/m^2; (2) Planned painless (intravenous sedation) colonoscopy; Trial 3 (Hysteroscopy/Painless Abortion Sedation) Specific Inclusion: Planned hysteroscopy/painless abortion or other short-term anaesthesia, using an opioid-propofol sedation protocol;
Exclusion criteria
Exclusion criteria: (1)Edentulism of both the upper and lower jaws (inability to retain the device), severe periodontal disease or mobile teeth, or a recent history of maxillofacial surgery or severe temporomandibular joint disorders; (2)Inability to tolerate an oral device, such as a severe gag reflex; (3)Active upper airway bleeding, or severe gastroesophageal reflux disease and/or a high risk of aspiration (patients requiring individual assessment for device suitability); (4)Inability to cooperate or presence of severe cardiopulmonary insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of morning hypertension on the day of surgery;Incidence of hypoxia;Incidence of hypoxia events during surgery (from anaesthesia induction to return to ward); | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of elective surgery postponement due to hypertension;Catecholamine and aldosterone levels in the blood upon waking for several consecutive days;Incidence of hypotension after anesthesia induction;Incidence of intraoperative hypertension;Incidence of major cardiovascular adverse events within 7 days after surgery;1. Vital signs monitoring: blood oxygen saturation (SpO?), mean arterial pressure (MAP), heart rate (HR);Total propofol dosage (mg);Operation time;Anaesthesia recovery time;Number of times urgent airway intervention is required;6. Adverse event records: body movement, choking cough, bradycardia (HR < 50 bpm), hypotension (blood pressure 30% below baseline);Incidence of intraoperative respiratory arrest;Incidence of airway intervention;Non-hypoxia related adverse events;Other indicators include general patient information, duration of surgery, recovery time (from cessation of anaesthesia to eye opening), and duration of anaesthesia (from induction to leaving the operating room);Patient satisfaction;Record the patient's heart rate, MAP, and SpO2 at the time of admission (T0), immediately at the start of surgery (T1), immediately at cervical dilation (T2), and immediately at the end of surgery (T3).; | — |
Countries
China
Contacts
Public ContactWang Liwei
Xuzhou Central HospitalXuzhou, Jiangsu, China
Outcome results
None listed