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

NCT06436638 | Recruiting

• 1 other identifier: KU-ERKAN-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Deep Sedation; Non-invasive Ventilation Support; Nasal Airway; Nasal CPAP Mask; Impacted Molar

Outcome Measures

Primary Outcomes (9)

• Non-invasive blood pressure

  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.

  Intraoperative period and for 4 hours after surgery

• ECG

  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.

  Intraoperative period and for 4 hours after surgery

• Peripheral oxygen saturation

  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.

  Intraoperative period and for 4 hours after surgery

• Respiratory rate

  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.

  Intraoperative period and for 4 hours after surgery

• Number of interruptions for an anesthesia-related reason

  Number of episodes during deep sedation when the procedure has to be interrupted due to desaturation or patient movement will be recorded

  Intraoperative period

• Tidal volume

  During non-invasive ventilatory support, set and actual tidal volume values will be recorded at regular intervals during the operation.

  Intraoperative period

• Peak pressure

  During non-invasive ventilatory support, peak pressure values will be recorded at regular intervals during the operation.

  Intraoperative period

• End tidal carbon dioxide level (EtCO2)

  During non-invasive ventilatory support, end tidal carbon dioxide values will be recorded at regular intervals during the operation.

  Intraoperative period

• Minute ventilation

  During non-invasive ventilatory support, minute ventilation values will be recorded.

  Intraoperative period

Secondary Outcomes (4)

• Postoperative complications related non-invasive ventilation support devices and sedation

  During the next 3 hours after the end of the operation

• Patient and surgeon satisfaction

  Perioperative period

• Total dose of medications used for sedation during the procedure

  Intraoperative period

• Recovery duration from anesthesia

  From the end of the operation until discharge to the ward

Study Arms (2)

Group Airway

Group to receive non-invasive ventilation support via nasal airway during dental extraction under deep sedation.

Device: Non-invasive ventilation support equipment

Group Mask

Group to receive non-invasive ventilation support via nasal CPAP mask during dental extraction under deep sedation

Device: Non-invasive ventilation support equipment

Interventions

Non-invasive ventilation support equipment DEVICE

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.

Group Airway; Group Mask

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

It is planned to investigate patients with a diagnosis of impacted molars, who have an indication for dental extraction, and who are scheduled for dental extraction under sedation.

You may qualify if:

• Volunteer adult patients aged 18-60 years
• Patients scheduled for impacted tooth extraction
• Cases with surgical time ≥20 minutes and ≤60 minutes
• American Society of Anaesthesiologists (ASA) physical status I and II patients
• Patients with BMI≤30

You may not qualify if:

• Patients under 18 years old-over 60 years old
• Surgeries with a procedure time over 1 hour or less than 20 minutes
• American Society of Anaesthesiologists (ASA) physical status III and higher patients
• Presence of conditions such as mental retardation that impair the patient's ability to make decisions about himself/herself
• Patients with respiratory system diseases such as asthma, chronic obstructive pulmonary disease (COPD) or airway hyperreactivity
• Patients with a condition that severely narrows the nasal passage opening (e.g. adenoid hypertrophy, etc.)
• Patients with BMI\>30
• Patients who refused to participate in the study

Sponsors & Collaborators

• Gözde Nur Erkan: lead
• TC Erciyes University: collaborator
• Kırıkkale University: collaborator

Study Sites (2)

Erciyes University Faculty of Dentistry

Kayseri, Turkey (Türkiye)

RECRUITING

Kırıkkale University Faculty of Dentistry

Kırıkkale, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.

  PMID: 27022303 BACKGROUND

• Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3.

  PMID: 37406462 BACKGROUND

• Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052.

  PMID: 31313720 BACKGROUND

Central Study Contacts

Gözde Nur Erkan, Asst. Prof.

CONTACT

+905054334692; dr.gozdenur@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Doctor, Medical Doctor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 31, 2024
• Study Start: July 2, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)