Effects of Different Inspiratory:Expiratory Ratios on Respiratory and Recovery Outcomes During Dental Procedures Under General Anesthesia in Pediatric Patients
NCT ID: NCT07323420
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2026-01-12
2026-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to 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.
No interventions assigned to 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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
2 Years
12 Years
ALL
Yes
Sponsors
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Kırıkkale University
OTHER
Responsible Party
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Gözde Nur Erkan
Assistant Professor
Locations
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Kırıkkale University, Faculty of Dentistry
Kırıkkale, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KU-ERKAN-004
Identifier Type: -
Identifier Source: org_study_id
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