Kırıkkale University, Faculty of Dentistry
Kirikkale, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07323420
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.
Interested in participating?
Request Info2 year–12 year
All sexes
Observational
Kirikkale, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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).
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).
Time frame: From 2 minutes before extubation to 2 minutes after extubation
The patient's physical response during removal of the endotracheal tube will be assessed by direct observation at the time of extubation. Responses will be evaluated once during the extubation process based on the presence of facial grimacing, upper extremity movement, lower extremity movement, or other observable involuntary motor responses.
Time frame: From extubation until 30 minutes after extubation
The occurrence of bronchospasm or laryngospasm during or immediately after extubation will be recorded. These events will be identified based on clinical signs such as increased airway resistance, wheezing, stridor, oxygen desaturation, or the need for medical intervention.
Time frame: Immediately before surgery (prior to operating room entry)
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS), which ranges from 23 to 100, with higher scores indicating greater levels of anxiety. The assessment will be performed before anesthesia induction.
Time frame: From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour
The Pediatric Anesthesia Emergence Delirium (PAED) scale is a validated observational tool used to assess the presence and severity of emergence delirium in pediatric patients after anesthesia. The scale consists of five items, with total scores ranging from 0 to 20, where higher scores indicate more severe emergence delirium.
Time frame: From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour
The Modified Aldrete Score assesses postoperative recovery, including activity, respiration, circulation, consciousness, and oxygen saturation. Total scores range from 0 to 10, with higher scores indicating more complete recovery.
Time frame: From end of surgery until transfer to the hospital ward, assessed up to 2 hours
Operating Room → Recovery Room: Time (in minutes) from the end of surgery to patient transfer from the operating room to the recovery room.
Recovery Room → Hospital Ward: Time (in minutes) from patient arrival in the recovery room to transfer to the hospital ward.
Contact information is provided by the study sponsor or research team.
Kırıkkale University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07521956
Pathologic Processes, Pathological Conditions, Signs and Symptoms
Chilliwack, British Columbia, Canada
View Trial DetailsNCT07523919
Colonic Diseases, Colorectal Cancer
Merkez, Gümüşhane Province, Turkey (Türkiye)
View Trial DetailsNCT07737587
Behavior, Pathologic Processes
Iğdır, Turkey (Türkiye)
View Trial DetailsNCT01287000
Behavior, Cancer
Durham, North Carolina, United States
View Trial Details