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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorKırıkkale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients whose parents or legal guardians decline participation.

Presence of adenoid hypertrophy >30%.

Macroglossia or retrognathia.

Severe obesity or developmental delay.

Trial population

The study will include pediatric patients aged 2 to 12 years who are scheduled to undergo routine dental procedures under general anesthesia at our faculty. Eligible participants are classified as American Society of Anesthesiologists (ASA) Physical Status I or II. Patients with airway anomalies, significant adenoid hypertrophy, macroglossia, retrognathia, severe obesity, developmental delays, or a history of delayed emergence from anesthesia will be excluded. Children requiring anesthesia for less than 1 hour or more than 3 hours, those with known pulmonary or airway diseases, neuromuscular disorders affecting respiration, or receiving medications that could alter spontaneous breathing during emergence (e.g., atropine, lidocaine, steroids) are also excluded. Written informed consent must be obtained from parents or legal guardians prior to participation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

75 Participants
are grouped into 3 trial groups
Group A: Group 1: Control
Group B: Group 2: I:E 1:2
Group C: Group 3: I:E 1:3

Trial outcomes

Primary outcomes

1

Post-Extubation Respiratory Quality

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 10 minutes after extubation
2

Respiratory Rate (RR)

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)
3

Peak Airway Pressure (PeakP)

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 25-35 minutes prior to extubation, up to 40 minutes if required)
4

Heart Rate

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)

Secondary outcomes

1

Physical Response During 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 2 minutes before extubation to 2 minutes after extubation
2

Occurrence of Bronchospasm or Laryngospasm

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
From extubation until 30 minutes after extubation
3

Preoperative Anxiety Level Assessed by the Modified Yale Preoperative Anxiety Scale (mYPAS)

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
Immediately before surgery (prior to operating room entry)
4

Pediatric Anesthesia Emergence Delirium (PAED) Score

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.