Mechanical PowerLMA-MPNCT07252674
Comparison of Laryngeal Mask Airway and Endotracheal Intubation on Mechanical Power in Pediatric Patients
An observational study of Mechanical Power, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to compare two commonly used airway management methods-Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT)-in pediatric patients undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Mechanical Power
- What is being tested?
- Laryngeal Mask Airway (LMA)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2025to 30 Jun 2026
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients aged 2-5 years and weighing 10-20 kg who will undergo elective surgery under general anesthesia at Konya City Hospital. Participants will be classified as ASA physical status I-III. Patients who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.
Who may be able to join
- Children aged 2-5 years
- Body weight between 10-20 kg
- Patients classified as ASA physical status I-III
- Elective surgery planned under general anesthesia
Who cannot join
- Presence of severe chronic lung disease (e.g., advanced bronchopulmonary dysplasia)
- Uncontrolled or severe bronchial asthma
- Severe cardiac failure (NYHA Class III-IV)
- Diagnosis of pulmonary hypertension
- History of major lung surgery
- Severe obesity (BMI > 95th percentile)
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- Children scheduled for abdominal or thoracic surgery
- Procedures expected to last longer than two hours
- Emergency surgeries
- Children and/or parents who decline participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Laryngeal Mask Airway Versus Endotracheal Intubation on Mechanical Power and Postoperative Respiratory Complications in Pediatric Patients: A Prospective Observational Study
This prospective observational study aims to compare two commonly used airway management methods-Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT)-in pediatric patients undergoing elective surgery under general anesthesia. The primary objective is to evaluate the impact of LMA and ETT on intraoperative mechanical power, an emerging indicator of ventilator-induced lung stress. Secondary objectives include assessing postoperative respiratory complications such as cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding episodes. No interventions will be assigned based on a study protocol; airway management will be determined solely by clinical requirements. Routine ventilator parameters will be recorded, and mechanical power will be calculated using a validated simplified formula.
Read the detailed description
This prospective, observational, single-center clinical study will be conducted in the Department of Anesthesiology and Reanimation at Konya City Hospital. The aim of the study is to compare the effects of Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT) on intraoperative mechanical power in pediatric patients aged 2-5 years undergoing elective surgical procedures under general anesthesia. Mechanical power, calculated from routinely measured ventilator parameters, reflects the energy delivered to the respiratory system and is considered an important marker of ventilator-induced lung injury. Understanding how different airway devices influence mechanical power may contribute to improving lung-protective ventilation strategies in pediatric anesthesia.
Randomization will not be applied in this study. Airway management (LMA or ETT) will be chosen solely by the attending anesthesiologist based on clinical needs, including procedure type, expected duration, and aspiration risk. A standardized anesthesia induction and maintenance protocol will be applied to all patients. Mechanical power will be measured at two time points: (1) immediately after securing the airway and (2) at the end of surgery before emergence. Postoperative respiratory complications-including cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding-will be systematically recorded in the Post-Anesthesia Care Unit (PACU).
To minimize observer bias, intraoperative mechanical power measurements and postoperative complication assessments will be performed by different members of the research team. No deviations from routine clinical practice will occur, and no additional interventions will be introduced. Based on the power analysis for the primary outcome, the study aims to include a total of 100 pediatric patients, with 50 patients in the LMA group and 50 patients in the ETT group.
The findings of this research are expected to provide new insights into the effects of different airway devices on mechanical power and to support the development of lung-protective anesthesia strategies in pediatric patients.
- Conditions
- Mechanical Power
- Being tested
- Laryngeal Mask Airway (LMA)
- Keywords
- Mechanical Power, Laryngeal Mask Airway, Endotracheal Intubation, Postoperative Respiratory Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask Airway (LMA)Procedure or surgery
Randomization is not applied in this study. Since the research is observational in nature, the allocation of patients to the LMA or ETT groups is not performed randomly; instead, it is determined by the attending anesthesiologist based on the type of surgery, clinical requirements, and the individual characteristics of the patient. Accordingly, the choice of airway management method is not influenced by the investigators; the treatment process proceeds according to routine clinical practice, prioritizing patient safety and established clinical standards.
Group 1: LMA Group Description: This cohort consists of pediatric patients in whom a Laryngeal Mask Airway (LMA) is used for airway management during surgery.
Group 2: ETT Group Description: This cohort consists of pediatric patients who undergo Endotracheal Intubation (ETT) for airway management during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: LMA Group | Group 2: ETT Group Receives: Procedure: Laryngeal Mask Airway (LMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical power (MP)
To compare the effects of laryngeal mask airway (LMA) and endotracheal intubation (ETT) on intraoperative mechanical power (MP) in pediatric patients aged 2-5 years undergoing elective surgery under general anesthesia.
Mechanical power (MP) will be assessed using ventilator-derived respiratory parameters (tidal volume, respiratory rate, PEEP, peak pressure, and plateau pressure). MP will be calculated using the following validated equation:
Mechanical Power (J/min) = 0.098 × RR × VT × (PEEP + ½(Pplat - PEEP) + (Ppeak - Pplat)).
Measured: Mechanical power will be measured twice during surgery, as follows: MP1: Immediately after airway placement, before the start of surgery. MP2: At the end of surgery, before the initiation of emergence.
Secondary outcomes (1)
Postoperative Respiratory Complications
Respiratory complications observed during the emergence period and in the Post-Anesthesia Care Unit (PACU), including cough, breath holding, laryngospasm, bronchospasm, increased secretions, and oxygen desaturation, will be systematically recorded.
Measured: From the start of emergence until discharge from PACU (assessed up to approximately 30 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Nov 2025
- Primary completion26 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical PowerStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Karaarslan, Konya City Hospital
- Investigators
- Esma Karaarslan, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252674
- Sponsor's protocol ID
- LMA-MP
- Acronym
- LMA-MP
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If data sharing is approved by the research team in the future, anonymized individual participant data (IPD) may be shared with qualified researchers upon reasonable request. Any shared data would exclude identifying information and would include only demographic variables and study-related measurements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Laryngeal Mask Airway Versus Endotracheal Intubation on Mechanical Power and Postoperative Respiratory Complications in Pediatric Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07252674
- Acronym / sponsor ID
- LMA-MP / LMA-MP
- Conditions
- Mechanical Power
- Keywords
- Mechanical Power, Laryngeal Mask Airway, Endotracheal Intubation, Postoperative Respiratory Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Nov 2025 (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 prospective observational study aims to compare two commonly used airway management methods-Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT)-in pediatric patients undergoing elective surgery under general anesthesia. The primary objective is to evaluate the impact of LMA and ETT on intraoperative mechanical power, an emerging indicator of ventilator-induced lung stress. Secondary objectives include assessing postoperative respiratory complications such as cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding episodes. No interventions will be assigned based on a study protocol; airway management will be determined solely by clinical requirements. Routine ventilator parameters will be recorded, and mechanical power will be calculated using a validated simplified formula.
Detailed description
This prospective, observational, single-center clinical study will be conducted in the Department of Anesthesiology and Reanimation at Konya City Hospital. The aim of the study is to compare the effects of Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT) on intraoperative mechanical power in pediatric patients aged 2-5 years undergoing elective surgical procedures under general anesthesia. Mechanical power, calculated from routinely measured ventilator parameters, reflects the energy delivered to the respiratory system and is considered an important marker of ventilator-induced lung injury. Understanding how different airway devices influence mechanical power may contribute to improving lung-protective ventilation strategies in pediatric anesthesia.
Randomization will not be applied in this study. Airway management (LMA or ETT) will be chosen solely by the attending anesthesiologist based on clinical needs, including procedure type, expected duration, and aspiration risk. A standardized anesthesia induction and maintenance protocol will be applied to all patients. Mechanical power will be measured at two time points: (1) immediately after securing the airway and (2) at the end of surgery before emergence. Postoperative respiratory complications-including cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding-will be systematically recorded in the Post-Anesthesia Care Unit (PACU).
To minimize observer bias, intraoperative mechanical power measurements and postoperative complication assessments will be performed by different members of the research team. No deviations from routine clinical practice will occur, and no additional interventions will be introduced. Based on the power analysis for the primary outcome, the study aims to include a total of 100 pediatric patients, with 50 patients in the LMA group and 50 patients in the ETT group.
The findings of this research are expected to provide new insights into the effects of different airway devices on mechanical power and to support the development of lung-protective anesthesia strategies in pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: LMA Group | – | Procedure: Laryngeal Mask Airway (LMA)Group 2: ETT Group |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients aged 2-5 years and weighing 10-20 kg who will undergo elective surgery under general anesthesia at Konya City Hospital. Participants will be classified as ASA physical status I-III. Patients who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.
Key inclusion criteria (4 listed)
- Children aged 2-5 years
- Body weight between 10-20 kg
- Patients classified as ASA physical status I-III
- Elective surgery planned under general anesthesia
Key exclusion criteria (10 listed)
- Presence of severe chronic lung disease (e.g., advanced bronchopulmonary dysplasia)
- Uncontrolled or severe bronchial asthma
- Severe cardiac failure (NYHA Class III-IV)
- Diagnosis of pulmonary hypertension
- History of major lung surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal Mask Airway (LMA)Randomization is not applied in this study. Since the research is observational in nature, the allocation of patients to the LMA or ETT groups is not performed randomly; instead, it is determined by the attending anesthesiologist based on the type of surgery, clinical requirements, and the individual characteristics of the patient. Accordingly, the choice of airway management method is not influenced by the investigators; the treatment process proceeds according to routine clinical practice, prioritizing patient safety and established clinical standards. Group 1: LMA Group Description: This cohort consists of pediatric patients in whom a Laryngeal Mask Airway (LMA) is used for airway management during surgery. Group 2: ETT Group Description: This cohort consists of pediatric patients who undergo Endotracheal Intubation (ETT) for airway management during surgery. | Procedure or surgery | Group 1: LMA Group |
Primary outcome
Mechanical power (MP)
Time frame: Mechanical power will be measured twice during surgery, as follows: MP1: Immediately after airway placement, before the start of surgery. MP2: At the end of surgery, before the initiation of emergence.
To compare the effects of laryngeal mask airway (LMA) and endotracheal intubation (ETT) on intraoperative mechanical power (MP) in pediatric patients aged 2-5 years undergoing elective surgery under general anesthesia. Mechanical power (MP) will be assessed using ventilator-derived respiratory parameters (tidal volume, respiratory rate, PEEP, peak pressure, and plateau pressure). MP will be calculated using the following validated equation: Mechanical Power (J/min) = 0.098 × RR × VT × (PEEP + ½(Pplat - PEEP) + (Ppeak - Pplat)).
1 secondary outcome
Postoperative Respiratory Complications
Time frame: From the start of emergence until discharge from PACU (assessed up to approximately 30 minutes).
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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. If data sharing is approved by the research team in the future, anonymized individual participant data (IPD) may be shared with qualified researchers upon reasonable request. Any shared data would exclude identifying information and would include only demographic variables and study-related measurements.
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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.
Esma Karaarslan, MD principal investigator
Konya City Hospital
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 Mechanical Power, run by Konya City Hospital 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 10 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 2 Jul 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?
Mechanical power (MP) (time frame: Mechanical power will be measured twice during surgery, as follows: MP1: Immediately after airway placement, before the start of surgery. MP2: At the end of surgery, before the initiation of emergence.). 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 2 Jul 2026.