Effects of Different Inspiratory:Expiratory Ratios on Respiratory and Recovery Outcomes During Dental Procedures Under General Anesthesia in Pediatric Patients

Kırıkkale University

Status: Enrolling

Conditions: Respiratory Function; General Anesthesia; Pediatric Anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT07323420

KU-ERKAN-004

Details and patient eligibility

About

This observational study aims to evaluate the effects of different inspiratory to expiratory (I:E) ratios (1:2 vs. 1:3) during mechanical ventilation in pediatric patients undergoing dental procedures under general anesthesia. Due to behavioral challenges, dental phobia, or medical conditions, general anesthesia is often required to ensure immobility and cooperation during dental treatments in children.

In the clinic where the study will be conducted, the I:E ratio is routinely adjusted approximately 20-30 minutes before the end of the procedure to facilitate a smoother transition to spontaneous breathing during emergence from anesthesia. While 1:2 is commonly used, the 1:3 ratio may improve respiratory efficiency and recovery by prolonging the expiratory phase.

The study aims to compare vital signs, respiratory parameters (heart rate, blood pressure, SpO₂, EtCO₂, respiratory rate), recovery quality, and respiratory complications between the two I:E ratios. The findings aim to optimize ventilation strategies and improve patient comfort and safety during emergence from anesthesia.

Full description

The recent study involves pediatric patients undergoing dental procedures under general anesthesia following routine and standard clinical protocols. No additional interventions beyond standard care will be applied.

Specifically for the study, a non-invasive, observational scoring system will be used during the emergence phase to assess respiratory quality without requiring any extra tests or procedures. The scoring includes observation of spontaneous breathing, accessory muscle use, airway patency, physical responses to painful stimuli, and coughing episodes.

Patients will receive the same anesthesia and dental treatment as those not included in the study. The study compares the effects of routine inspiratory:expiratory (I:E) ratios used during mechanical ventilation on respiratory and recovery outcomes.

Variables assessed include vital and respiratory parameters (heart rate, blood pressure, SpO₂, EtCO₂, respiratory rate, peak airway pressure, time to spontaneous breathing, and physical/hemodynamic responses during spontaneous breathing), respiratory quality post-extubation (evaluated via the study-specific scale), and recovery parameters (physical responses during airway suctioning/extubation, presence of bronchospasm/ laryngospasm, agitation levels measured preoperatively by Modified Yale Preoperative Anxiety Scale and postoperatively by the Pediatric Anesthesia Emergence Delirium Scale (PAED), Modified Aldrete score, and discharge times from recovery and hospital wards).

All data will be recorded in a patient tracking form prepared for the study. Induction, maintenance, emergence from anesthesia, and management of any complications will follow routine clinical practice without any changes. No modifications to anesthesia or dental treatment protocols will be required for the study.

Enrollment: 75 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pediatric patients scheduled for dental procedures under general anesthesia at our faculty.
• American Society of Anesthesiologists (ASA) Physical Status I or II.
• Age between 2 and 12 years.
• Written informed consent obtained from parents or legal guardians.

Exclusion criteria

• Patients whose parents or legal guardians decline participation.
• Presence of adenoid hypertrophy >30%.
• Macroglossia or retrognathia.
• Severe obesity or developmental delay.
• History of delayed emergence from anesthesia.
• ASA Physical Status III or higher.
• Anesthesia duration less than 1 hour or more than 3 hours.
• Patients with difficult airway management or ventilation.
• Known pulmonary or airway diseases or anomalies.
• Use of pharmacological agents that may affect spontaneous respiratory quality.
• Presence of neuromuscular disorders affecting respiratory function.
• Age <2 years or >12 years.
• Administration of medications intraoperatively or preoperatively that may influence respiratory dynamics during emergence (e.g., atropine, lidocaine, steroids).

Trial design

75 participants in 3 patient groups

Group 1: Control

Description:

Patients who emerge from anesthesia earlier than planned without pre-emergence preparation. A minimum of 15 patients will be enrolled in this group.

Group 2: I:E 1:2

Description:

Patients undergoing standart dental procedures under general anesthesia; during the last phase of the procedure, mechanical ventilation will be applied with an I:E ratio of 1:2. A minimum of 30 patients will be enrolled in this group.

Group 3: I:E 1:3

Description:

Patients undergoing standart dental procedures under general anesthesia; during the last phase of the procedure, mechanical ventilation will be applied with an I:E ratio of 1:3. A minimum of 30 patients will be enrolled in this group.