Ventilation Therapy; ComplicationsNCT06612125
Comparing Different Startegies of Positive Pressure Ventilation in Children
A study of Ventilation Therapy; Complications, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand, Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation Therapy; Complications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 1 and 5 years.
- patient scheduled for laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists classification of physical status of I-II.
Who cannot join
- cardiopulmonary disease.
- severe hepatorenal dysfunction.
- history of upper respiratory tract infection 2 weeks before the operation.
- overweight [more than 20% of standard body weight].
- neuromuscular disease.
- anticipated difficult airway.
- hiatus hernia or gastroesophageal reflux disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benisuef university hospital
Benisuef
Mariana As Mansour, MD, 01222960009, mrmrsyk4@gmail.com
About this study
Official title: Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study
The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,
Read the detailed description
The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- volume controlled ventilation, pressure controlled ventilation, pressure controlled volume grantanteed ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume controlled ventilationOther
Pediatric patients in the VCV group (n= 30) received volume-controlled ventilation, target tidal volume was set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.
pressure controlled ventilationOther
Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.
pressure controlled volume grantanteed ventilationOther
Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.
| Study group | Role | What they receive |
|---|---|---|
| vCV group | Active comparator | Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O. Receives: Other: volume controlled ventilation |
| PCV group | Active comparator | Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O. Receives: Other: pressure controlled ventilation |
| PCV-VG group | Active comparator | Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2. Receives: Other: pressure controlled volume grantanteed ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
(PIP)
peak inspiratory pressure
Measured: within one hour
Pplat
plateau airway pressure
Measured: within one hour
(Cdyn)
pulmonary dynamic compliance
Measured: within one hour
(RAW
airway resistance
Measured: within one hour
VT
exhaled tidal volume
Measured: within one hour
EtCO2
end-expiratory carbon dioxide
Measured: within one hour
Vd/VT
physiologic dead space over tidal volume
Measured: within one hour
Secondary outcomes (3)
(MAP)
mean arterial pressure
Measured: within one hour
(HR)
heart rate
Measured: within one hour
postoperative respiratory adverse events
cough, hoarseness, sore throat, hypoxemia, laryngospasm, bronchospasm.
Measured: within 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Soliman, Beni-Suef University
- Investigators
- Mariana as Mansour, MD, Principal investigator, benisuef university hospital Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612125
- Sponsor's protocol ID
- FMBSUREC/01092024/Mansour
- Status last verified
- Jan 2025
- First submitted
- 21 Sep 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mansour MA, Mahmoud HE, AbdElAzeem HN, Fakhry DM. Comparison of positive pressure ventilation strategies in young children undergoing laparoscopic inguinal hernia repair with laryngeal mask airway: a prospective randomized study. BMC Anesthesiol. 2025 Dec 19;26(1):51. doi: 10.1186/s12871-025-03541-w.
PubMed 41420209
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06612125
- Acronym / sponsor ID
- FMBSUREC/01092024/Mansour
- Conditions
- Ventilation Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,
Detailed description
The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vCV group | Active comparator | Other: volume controlled ventilationPediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O. |
| PCV group | Active comparator | Other: pressure controlled ventilationPediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O. |
| PCV-VG group | Active comparator | Other: pressure controlled volume grantanteed ventilationPediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 1 and 5 years.
- patient scheduled for laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists classification of physical status of I-II.
Key exclusion criteria (7 listed)
- cardiopulmonary disease.
- severe hepatorenal dysfunction.
- history of upper respiratory tract infection 2 weeks before the operation.
- overweight [more than 20% of standard body weight].
- neuromuscular disease.
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 |
|---|---|---|
| volume controlled ventilationPediatric patients in the VCV group (n= 30) received volume-controlled ventilation, target tidal volume was set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2. | Other | vCV group |
| pressure controlled ventilationPediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O. | Other | PCV group |
| pressure controlled volume grantanteed ventilationPediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2. | Other | PCV-VG group |
Primary outcome
(PIP)
Time frame: within one hour
peak inspiratory pressure
Pplat
Time frame: within one hour
plateau airway pressure
(Cdyn)
Time frame: within one hour
pulmonary dynamic compliance
(RAW
Time frame: within one hour
airway resistance
VT
Time frame: within one hour
exhaled tidal volume
EtCO2
Time frame: within one hour
end-expiratory carbon dioxide
Vd/VT
Time frame: within one hour
physiologic dead space over tidal volume
3 secondary outcomes
(MAP)
Time frame: within one hour
(HR)
Time frame: within one hour
postoperative respiratory adverse events
Time frame: within 24 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 41420209Mansour MA, Mahmoud HE, AbdElAzeem HN, Fakhry DM. Comparison of positive pressure ventilation strategies in young children undergoing laparoscopic inguinal hernia repair with laryngeal mask airway: a prospective randomized study. BMC Anesthesiol. 2025 Dec 19;26(1):51. doi: 10.1186/s12871-025-03541-w.
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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.
Mariana as Mansour, MD principal investigator
benisuef university hospital Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Ventilation Therapy; Complications, run by Beni-Suef University at 1 site in Egypt.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana AS Mansour, MD (01222960009 ext. Benisuef, mrmrsyk4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(PIP) (time frame: within one hour). The study lists 7 primary outcomes in all. 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 NCT06612125, which also lists 1 linked publication.
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 Jan 2025.