A Clinical Study on the Effects of Different Inspiratory:Expiratory Ratios on Respiratory Function and Recovery in Pediatric Patients Undergoing Dental Procedures Under General Anesthesia
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kırıkkale University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Post-Extubation Respiratory Quality
Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group 1: Control
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
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
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.
Outcomes
Primary Outcomes
Post-Extubation Respiratory Quality
Time Frame: During 10 minutes after extubation
Respiratory quality will be assessed using a study-specific observational scale (range 0-10; higher scores indicate poorer respiratory quality). Components include spontaneous breathing adequacy, accessory muscle use, airway patency, response to painful stimuli, and coughing episodes.
Respiratory Rate (RR)
Time Frame: During the emergence preparation period (approximately 25-35 minutes prior to extubation, up to 40 minutes if required)
Mean respiratory rate (breaths/min) recorded during spontaneous breathing while EtCO₂ is maintained within the standardized target range, for each I:E ratio group (1:2 vs. 1:3).
Peak Airway Pressure (PeakP)
Time Frame: During the emergence preparation period (approximately 25-35 minutes prior to extubation, up to 40 minutes if required)
Peak airway pressure (cmH₂O) recorded during emergence preparation period for each I:E ratio group (1:2 vs. 1:3).
Heart Rate
Time Frame: During the emergence preparation period (approximately 20-30 minutes prior to extubation, up to 40 minutes if required)
Mean heart rate (beats/min) recorded during spontaneous breathing while EtCO₂ and sevoflurane MAC are maintained within the standardized target range, for each I:E ratio group (1:2 vs. 1:3).
Blood Pressure
Time Frame: During the emergence preparation period (approximately 20-30 minutes prior to extubation, up to 40 minutes if required)
Mean arterial blood pressure (mmHg) recorded during spontaneous breathing while EtCO₂ and sevoflurane MAC are maintained within the standardized target range, for each I:E ratio group (1:2 vs. 1:3).
Secondary Outcomes
- Physical Response During Extubation(From 2 minutes before extubation to 2 minutes after extubation)
- Occurrence of Bronchospasm or Laryngospasm(From extubation until 30 minutes after extubation)
- Preoperative Anxiety Level Assessed by the Modified Yale Preoperative Anxiety Scale (mYPAS)(Immediately before surgery (prior to operating room entry))
- Pediatric Anesthesia Emergence Delirium (PAED) Score(From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour)
- Modified Aldrete Score(From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour)
- Postoperative transfer times(From end of surgery until transfer to the hospital ward, assessed up to 2 hours)
Investigators
Gözde Nur Erkan
Assistant Professor
Kırıkkale University