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

NCT07323420 | Recruiting

• 1 other identifier: KU-ERKAN-004
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Function; Pediatric Anesthesia; General Anesthesia

Keywords

General Anesthesia; Anesthesia Recovery; Emergence from Anesthesia; Mechanical Ventilation; I:E Ratio; Recovery Quality

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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).

  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).

  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).

  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

  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

Study Arms (3)

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.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University, Faculty of Dentistry

Kırıkkale, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gözde Nur Erkan Assisstant Professor

CONTACT

+903182244927; dr.gozdenur@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)