Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-invasive ventilation support equipment: Non-invasive ventilation support is provided by nasal airway and nasal CPAP mask to avoid respiratory complications such as hypoxia, desaturation, hypercarbia, respiratory depression etc. during extraction of impacted molars under deep sedation.

Study summary

In patients with high levels of fear and anxiety, it is recommended to perform dental procedures under sedation or general anesthesia depending on the nature of the procedure. In dental treatment under anesthesia, it is important that the procedure is comfortable and well tolerated by the patient. In addition, patient comfort is important in all dental procedures to prevent the development of avoidance behavior.

During dental procedures performed under anesthesia, the oral cavity is completely within the scope of the surgical or procedure field. In this respect, sedation and general anesthesia in dental procedures and operations have specific risks and challenges.Since there is a risk of respiratory depression, hypoxia and hypercarbia during deep sedation, non-invasive ventilation support provided to patients with airway devices would be beneficial. In the research clinics where the study will be conducted, deep sedation with non-invasive mechanical ventilation support using a nasal CPAP (Continuous Positive Airway Pressure) mask or nasal airway is applied during the extraction of impacted molars. Thus, many dental procedures are routinely performed under deep sedation without the need for general anesthesia. There are very limited data in the literature on the use of a nasal CPAP mask during sedation for different procedures in patients with obstructive sleep apnea or obesity. However, no study comparing ventilation support during deep sedation with nasal CPAP mask and nasal airway has been found in the literature.

The aim of this study is to compare the non-invasive ventilation support provided with 2 different airway devices during the procedure in terms of intraoperative and postoperative related complications, ventilation parameters, patient and surgeon satisfaction.

The hypothesis of the study is that two different ventilation support methods during deep sedation may be superior to each other in terms of anesthesia quality, postoperative complications related to airway devices, patient and surgeon satisfaction.

In the study, a total of 60 patients (Group airway, n;30, Group Mask, n;30) from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial \>0.8.

The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included.

Eligibility

Primary outcome measure(s)

• Non-invasive blood pressure — Intraoperative period and for 4 hours after surgery
  It is planned to record non-invasive blood pressure values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Changes in blood pressure above 20% from baseline will be recorded additionally.
• ECG — Intraoperative period and for 4 hours after surgery
  It is planned to record heart rate values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Changes in heart rate greater than 20% of baseline will be recorded additionally.
• Peripheral oxygen saturation — Intraoperative period and for 4 hours after surgery
  It is planned to record peripheral oxygen saturation values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Hypoxia (SpO2\<90%) will be recorded additionally.
• Respiratory rate — Intraoperative period and for 4 hours after surgery
  It is planned to record respiratory rate values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Respiratory depression will be recorded additionally.
• Number of interruptions for an anesthesia-related reason — Intraoperative period
  Number of episodes during deep sedation when the procedure has to be interrupted due to desaturation or patient movement will be recorded
• Tidal volume — Intraoperative period
  During non-invasive ventilatory support, set and actual tidal volume values will be recorded at regular intervals during the operation.
• Peak pressure — Intraoperative period
  During non-invasive ventilatory support, peak pressure values will be recorded at regular intervals during the operation.
• End tidal carbon dioxide level (EtCO2) — Intraoperative period
  During non-invasive ventilatory support, end tidal carbon dioxide values will be recorded at regular intervals during the operation.
• Minute ventilation — Intraoperative period
  During non-invasive ventilatory support, minute ventilation values will be recorded.

Trial sites (2)

Other trials for the same condition