Mechanical Ventilation ComplicationNCT05127317
Mechanical Power in Pediatric Mechanical Ventilation
An observational study of Mechanical Ventilation Complication and Aediatric Anesthesia, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
Mechanical power is the amount of energy transferred to the respiratory system of patients during each breath period. After overcoming the resistances required for respiration, the remaining energy may end up by damaging the lung parenchyma. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication, Aediatric Anesthesia
- What is being tested?
- Mechanical power
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2021to 10 Jan 2022
- 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 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All patients under the age of 18 who will undergo laparoscopic lower abdomen surgery under general anesthesia under elective conditions.
Who may be able to join
- To undergo laparoscopic lower abdomen surgery under general anesthesia under elective conditions under the age of 18
Who cannot join
- Patients in both groups weill be excluded if they had uncorrected congenital heart disease, pre-existing lung or airway disease, conditions that may decrease chest wall compliance, chronic respiratory failure requiring long-term MV, and tracheostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Mechanical Power be Used as a Safety Precaution in Pediatric Patients?
Mechanical power is the amount of energy transferred to the respiratory system of patients during each breath period. After overcoming the resistances required for respiration, the remaining energy may end up by damaging the lung parenchyma. Promising studies are showing that this amount of energy, which can be calculated mathematically, can be used as a single indicator instead of the limits used for barotrauma, volu-trauma, or atelecto-trauma in adult patients. However, the MP limit that should not be exceeded in pediatric patients is not yet clear. In this study, we present our MP calculations in pediatric anesthesia
Read the detailed description
Mechanical ventilation is applied to millions of healthy and sick lungs every year in perioperative conditions and intensive care units. Meanwhile, the energy applied to the lungs by the ventilator during mechanical ventilation is usually used to overcome resistance in the chest wall and airways. Leftover energy is consumed by temperature, inflammation, and potentially lung tissue damage (1). The risk of ventilation-related damage increases in lungs with impaired homogeneity and ventilation-perfusion imbalance (1). As demonstrated by experimental and clinical studies, mechanical ventilation-induced lung injury (VILI) is associated with tidal volume, peak pressure, respiratory rate, and airflow. The physical force applied during ventilation TV increases exponentially with driving pressures (ΔPaw), flow (exponent = 2), and respiration rate (RR) (exponent = 1.4), and linearly with positive end-expiratory pressure (PEEP) (2). When the effects of these parameters are formulated, the energy applied to the lungs is revealed. This energy has been formulated as Joule/minute and has now taken its place as mechanical power (MP) in the literature. (2). A benefit of the MP calculation is that it is a single, easily calculated indicator parameter that can be used for the risks of barotrauma, volutrauma, or atelectotrauma associated with VILI. As shown in different publications, high MP values were associated with negative outcomes such as increased 30-day mortality in intensive care patients, increased length of stay in hospital and intensive care unit, and decreased number of ventilator-free days(3)(4). Cressoni et al. showed in their experimental study that MP values above 12 J/min in healthy pigs are associated with MV-related complications and this value can also be used as an alarm limit in humans(5). In addition, Costa et al found that 0.32 ± 0.14 J / min/ kg indexed MP(MP/Kg) was associated with increased mortality in ARDS patients(6). Some recent studies also support the conclusion that Mp calculation is beneficial(7)(8). For this reason, Gattinoni et al. suggests that MP limits and formula should be added to the mechanical ventilator software(2). However, studies on MP have often focused on ARDS and have been performed on intensive care patients or experimental animal models(9). Although MP is a promising safety limit with its easy computability, there are still questions about the formula and its usefulness. The success of the MP formula in perioperative situations and especially in pediatric patients has not been adequately tested. As far as we know, our study is one of the first publications to question the MP threshold in healthy pediatric cases.
In this study, our primary aim is to calculate the MP applied in pediatric cases who will undergo inguinal hernia surgery under general anesthesia.
Our other aims are the calculation of the mechanical power applied per kilogram and the other transferred energies, their comparison with the literature, and questioning the possible contribution of a mechanical power formula to safe mechanical ventilation in pediatric cases.
- Being tested
- Mechanical power
- Keywords
- mechanical ventilation, pediatric anesthesia, mechanical power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical powerDiagnostic test
In our study, mechanical power (MP) will be calculated during mechanical ventilation in patients who will be operated under general anesthesia.
MP will be calculated with the simplified formula applied by Gattinoni et al. MPvcv: RR x Tv x (PIP-[(Pplat-PEEP)/2]) x 0.098(2) In pressure-controlled ventilation, the simplified MP formula of Becher et al. well be used.
MPpcv: RR x Tv x (ΔPinsp + PEEP) x 0.098 (11)
For MP calculated according to the weight of the patients; Indexed MP: MP /kg according to IBW. For the force applied to the lungs in each inspiration; Dynamic power (mJ/min): Vt x RR x [(Pplato+ tPEEP)/2]. For the driver power that provides the gas flow; Driving power (mJ/min): Vt x RR x [ (Pplat - tPEEP) / 2]. Calculating mechanical energy; Mechanical energy (mJ/kg): 0.098 x (V x kg ) x (PIP - [(P plateau- PEEP) / 2]) formulas were used
What is being measured
The primary outcome is the main question the study is designed to answer.
median mechanical power
mechanical force applied to the lungs during mechanical ventilation, calculated according to the formula
Measured: Measurements will be taken after half an hour of mechanical ventilation.
Secondary outcomes (1)
indexed mechanical power
mechanical power and other mechanical ventilator parameters applied according to the weight of the patients
Measured: Data will be obtained at the beginning of the operation and after half an hour of ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Aug 2021
- Primary completion10 Dec 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet YUKSEK, Bozok University
- Investigators
- Ahmet YUKSEK, asst.prof, Study chair, Yozgat Bozok Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127317
- Sponsor's protocol ID
- 2017-KAEK-02082021
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kneyber MCJ. Driving Pressure and Mechanical Power: The Return of Physiology in Pediatric Mechanical Ventilation. Pediatr Crit Care Med. 2021 Oct 1;22(10):927-929. doi: 10.1097/PCC.0000000000002829. No abstract available.
PubMed 34605787Becher T, van der Staay M. Calculation of mechanical power for pressure-controlled ventilation: author's reply. Intensive Care Med. 2019 Oct;45(10):1498-1499. doi: 10.1007/s00134-019-05742-7. Epub 2019 Aug 20. No abstract available.
PubMed 31432217
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mechanical Power be Used as a Safety Precaution in Pediatric Patients?
- ClinicalTrials.gov ID
- NCT05127317
- Acronym / sponsor ID
- 2017-KAEK-02082021
- Keywords
- mechanical ventilation, pediatric anesthesia, mechanical power
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 19 Nov 2021 (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.
Mechanical power is the amount of energy transferred to the respiratory system of patients during each breath period. After overcoming the resistances required for respiration, the remaining energy may end up by damaging the lung parenchyma. Promising studies are showing that this amount of energy, which can be calculated mathematically, can be used as a single indicator instead of the limits used for barotrauma, volu-trauma, or atelecto-trauma in adult patients. However, the MP limit that should not be exceeded in pediatric patients is not yet clear. In this study, we present our MP calculations in pediatric anesthesia
Detailed description
Mechanical ventilation is applied to millions of healthy and sick lungs every year in perioperative conditions and intensive care units. Meanwhile, the energy applied to the lungs by the ventilator during mechanical ventilation is usually used to overcome resistance in the chest wall and airways. Leftover energy is consumed by temperature, inflammation, and potentially lung tissue damage (1). The risk of ventilation-related damage increases in lungs with impaired homogeneity and ventilation-perfusion imbalance (1). As demonstrated by experimental and clinical studies, mechanical ventilation-induced lung injury (VILI) is associated with tidal volume, peak pressure, respiratory rate, and airflow. The physical force applied during ventilation TV increases exponentially with driving pressures (ΔPaw), flow (exponent = 2), and respiration rate (RR) (exponent = 1.4), and linearly with positive end-expiratory pressure (PEEP) (2). When the effects of these parameters are formulated, the energy applied to the lungs is revealed. This energy has been formulated as Joule/minute and has now taken its place as mechanical power (MP) in the literature. (2). A benefit of the MP calculation is that it is a single, easily calculated indicator parameter that can be used for the risks of barotrauma, volutrauma, or atelectotrauma associated with VILI. As shown in different publications, high MP values were associated with negative outcomes such as increased 30-day mortality in intensive care patients, increased length of stay in hospital and intensive care unit, and decreased number of ventilator-free days(3)(4). Cressoni et al. showed in their experimental study that MP values above 12 J/min in healthy pigs are associated with MV-related complications and this value can also be used as an alarm limit in humans(5). In addition, Costa et al found that 0.32 ± 0.14 J / min/ kg indexed MP(MP/Kg) was associated with increased mortality in ARDS patients(6). Some recent studies also support the conclusion that Mp calculation is beneficial(7)(8). For this reason, Gattinoni et al. suggests that MP limits and formula should be added to the mechanical ventilator software(2). However, studies on MP have often focused on ARDS and have been performed on intensive care patients or experimental animal models(9). Although MP is a promising safety limit with its easy computability, there are still questions about the formula and its usefulness. The success of the MP formula in perioperative situations and especially in pediatric patients has not been adequately tested. As far as we know, our study is one of the first publications to question the MP threshold in healthy pediatric cases.
In this study, our primary aim is to calculate the MP applied in pediatric cases who will undergo inguinal hernia surgery under general anesthesia.
Our other aims are the calculation of the mechanical power applied per kilogram and the other transferred energies, their comparison with the literature, and questioning the possible contribution of a mechanical power formula to safe mechanical ventilation in pediatric cases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients under the age of 18 who will undergo laparoscopic lower abdomen surgery under general anesthesia under elective conditions.
Key inclusion criteria (1 listed)
- To undergo laparoscopic lower abdomen surgery under general anesthesia under elective conditions under the age of 18
Key exclusion criteria (1 listed)
- Patients in both groups weill be excluded if they had uncorrected congenital heart disease, pre-existing lung or airway disease, conditions that may decrease chest wall compliance, chronic respiratory failure requiring long-term MV, and tracheostomy.
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 |
|---|---|---|
| Mechanical powerIn our study, mechanical power (MP) will be calculated during mechanical ventilation in patients who will be operated under general anesthesia. MP will be calculated with the simplified formula applied by Gattinoni et al. MPvcv: RR x Tv x (PIP-[(Pplat-PEEP)/2]) x 0.098(2) In pressure-controlled ventilation, the simplified MP formula of Becher et al. well be used. MPpcv: RR x Tv x (ΔPinsp + PEEP) x 0.098 (11) For MP calculated according to the weight of the patients; Indexed MP: MP /kg according to IBW. For the force applied to the lungs in each inspiration; Dynamic power (mJ/min): Vt x RR x [(Pplato+ tPEEP)/2]. For the driver power that provides the gas flow; Driving power (mJ/min): Vt x RR x [ (Pplat - tPEEP) / 2]. Calculating mechanical energy; Mechanical energy (mJ/kg): 0.098 x (V x kg ) x (PIP - [(P plateau- PEEP) / 2]) formulas were used | Diagnostic test | – |
Primary outcome
median mechanical power
Time frame: Measurements will be taken after half an hour of mechanical ventilation.
mechanical force applied to the lungs during mechanical ventilation, calculated according to the formula
1 secondary outcome
indexed mechanical power
Time frame: Data will be obtained at the beginning of the operation and after half an hour of ventilation
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 11 Jul 2022.
- Results publication: PubMed 34605787Kneyber MCJ. Driving Pressure and Mechanical Power: The Return of Physiology in Pediatric Mechanical Ventilation. Pediatr Crit Care Med. 2021 Oct 1;22(10):927-929. doi: 10.1097/PCC.0000000000002829. No abstract available.
- Results publication: PubMed 31432217Becher T, van der Staay M. Calculation of mechanical power for pressure-controlled ventilation: author's reply. Intensive Care Med. 2019 Oct;45(10):1498-1499. doi: 10.1007/s00134-019-05742-7. Epub 2019 Aug 20. No abstract available.
- Individual participant dataSharing planned: No
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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.
Ahmet YUKSEK, asst.prof study chair
Yozgat Bozok Universitesi
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 Ventilation Complication and Aediatric Anesthesia, run by Bozok 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 1 inclusion and 1 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 11 Jul 2022. 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?
median mechanical power (time frame: Measurements will be taken after half an hour of mechanical ventilation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127317, which also lists 2 linked publications.
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 11 Jul 2022.