Respiratory FunctionNCT07323420
Effects of Different Inspiratory:Expiratory Ratios on Respiratory and Recovery Outcomes During Dental Procedures Under General Anesthesia in Pediatric Patients
An observational study of Respiratory Function and Pediatric Anesthesia, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function, Pediatric Anesthesia, General Anesthesia
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 14 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University, Faculty of Dentistry
Kirikkale
About this study
Official title: 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
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.
Read the 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.
- Keywords
- General Anesthesia, Anesthesia Recovery, Emergence from Anesthesia, Mechanical Ventilation, I:E Ratio, Recovery Quality
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 10 minutes after extubation
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).
Measured: During the emergence preparation period (approximately 25-35 minutes prior to extubation, up to 40 minutes if required)
Peak Airway Pressure (PeakP)
Peak airway pressure (cmH₂O) recorded during emergence preparation period for each I:E ratio group (1:2 vs. 1:3).
Measured: During the emergence preparation period (approximately 25-35 minutes prior to extubation, up to 40 minutes if required)
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).
Measured: During the emergence preparation period (approximately 20-30 minutes prior to extubation, up to 40 minutes if required)
Blood Pressure
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).
Measured: During the emergence preparation period (approximately 20-30 minutes prior to extubation, up to 40 minutes if required)
Secondary outcomes (6)
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.
Measured: From 2 minutes before extubation to 2 minutes after extubation
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.
Measured: From extubation until 30 minutes after extubation
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.
Measured: Immediately before surgery (prior to operating room entry)
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.
Measured: From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour
Modified Aldrete Score
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.
Measured: From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour
Postoperative transfer times
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.
Measured: From end of surgery until transfer to the hospital ward, assessed up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Apr 2026
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Nur Erkan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323420
- Sponsor's protocol ID
- KU-ERKAN-004
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared; however, the dataset will be made available upon reasonable request to the corresponding author, subject to approval and relevant ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07323420
- Acronym / sponsor ID
- KU-ERKAN-004
- Keywords
- General Anesthesia, Anesthesia Recovery, Emergence from Anesthesia, Mechanical Ventilation, I:E Ratio, Recovery Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Physical Response During Extubation
Time frame: From 2 minutes before extubation to 2 minutes after extubation
Occurrence of Bronchospasm or Laryngospasm
Time frame: From extubation until 30 minutes after extubation
Preoperative Anxiety Level Assessed by the Modified Yale Preoperative Anxiety Scale (mYPAS)
Time frame: Immediately before surgery (prior to operating room entry)
Pediatric Anesthesia Emergence Delirium (PAED) Score
Time frame: From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour
Modified Aldrete Score
Time frame: From emergence from anesthesia through recovery unit stay until discharge, assessed up to 1 hour
Postoperative transfer times
Time frame: From end of surgery until transfer to the hospital ward, assessed up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared; however, the dataset will be made available upon reasonable request to the corresponding author, subject to approval and relevant ethical considerations.
Related trials for Respiratory Function
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Function and Pediatric Anesthesia, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Extubation Respiratory Quality (time frame: During 10 minutes after extubation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.