Cardiac Congenital DefectsNCT06076395
Volume Versus Pressure Ventilation on Lung Atelectasis
A study testing LMA (Laryngeal Mask Airway) in people with Cardiac Congenital Defects, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Cardiac Congenital Defects
- What is being tested?
- LMA (Laryngeal Mask Airway)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2024to Aug 2024
- Phase
- Interventional
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes.
Who cannot join
- Lung score at different times.
- Age \<2 years and \>6 years.
- Preoperative mechanical ventilation.
- Heart failure (any inotropic support infusion).
- Patients with any lung diseases( acute respiratory disease, pulmonary or lung
- diseases).
Show all 10Show fewer
- Lung consolidation score ≥ 2 before insertion of LMA.
- Any contraindication for LMA insertion (risk for aspiration, and/or airway
- obstruction below the larynx.)
- Procedures exceeding 120 mins duration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Volume Controlled Versus Pressure Ventilation on Anesthesia Induced Lung Atelectasis in Pediatrics Using Laryngeal Mask Airway (LMA )During Cardiac Catheterization. A Prospective Randomized Study.
This prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.
Read the detailed description
The initial US scanning will be done prior to the induction of anesthesia. Induction of anesthesia using 4% sevoflurane. Adequate size LMA will be inserted after adequate depth of anesthesia adjusted.
Group A (n=25): will receive pressure-controlled ventilation (PCV). Group B (n=25): will receive volume-controlled ventilation (VCV).
US scanning and Arterial blood gases at the following:
- T1(After maintenance of anesthesia).
- T2 (One minute after applying groin bandage and before extubation).
- T3 (10 minutes after extubation and resumption of adequate regular breathing).
- T4 (30 min post extubation).
- Conditions
- Cardiac Congenital Defects
- Being tested
- LMA (Laryngeal Mask Airway)
- Keywords
- pediatric cardiac catheterization, lung ultrasound score, lung atelectasis, LMA
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA (Laryngeal Mask Airway)Device
Also called Lung Ultrasound
Pressure controlled versus Volume controlled ventilation using LMA
| Study group | Role | What they receive |
|---|---|---|
| Group A pressure control ventilation | Experimental | Inspiratory pressure was adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O and FiO2 at 0.5 providing that the maximum airway pressure was limited to 25 cmH2O. Receives: Device: LMA (Laryngeal Mask Airway) |
| Group B volume control ventilation | Experimental | VT adjacent to 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and PEEP at 4 cm H2O and FiO2 at 0.5. Receives: Device: LMA (Laryngeal Mask Airway) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative incidence of Lung atelectasis immediate post-removal of LMA.
calculate lung score using lung ultrasound
Measured: immediated post removal of LMA
Secondary outcomes (1)
Correlation between lung score and PaO2 /FiO2 ratio
Arterial blood gases (ABG) in different time
Measured: From the preoperative period (T0) to 30 minutes post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start12 Jan 2024
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac Congenital DefectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For group A pressure control ventilation will be adjusted as follows: Inspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H 2 O and FiO2 at 0.5 providing that the maximum airway pressure will be limited to 25 cmH2O. For group B volume control ventilation will be adjusted as follows: tidal volume (VT) adjacent to 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and positive end expiratory pressure (PEEP)at 4 cmH2O and FiO2 at 0.5.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Saad Abd-El Kader, Kasr El Aini Hospital
- Investigators
- Amel Hanfy Abo El- Ela, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076395
- Sponsor's protocol ID
- MS-96-2023
- Status last verified
- Jan 2024
- First submitted
- 27 Sep 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedenstierna G. Airway closure, atelectasis and gas exchange during anaesthesia. Minerva Anestesiol. 2002 May;68(5):332-6.
PubMed 12029240Stefanik E, Drewnowska O, Lisowska B, Turek B. Causes, Effects and Methods of Monitoring Gas Exchange Disturbances during Equine General Anaesthesia. Animals (Basel). 2021 Jul 9;11(7):2049. doi: 10.3390/ani11072049.
PubMed 34359177Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, Crimella F, Cressoni M, Mojoli F. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761-1768. doi: 10.1097/CCM.0000000000003340.
PubMed 30048331Rodriguez-Fanjul J, Corsini I, Orti CS, Bobillo-Perez S, Raimondi F. Lung ultrasound to evaluate lung recruitment in neonates with respiratory distress (RELUS study). Pediatr Pulmonol. 2022 Oct;57(10):2502-2510. doi: 10.1002/ppul.26066. Epub 2022 Jul 12.
PubMed 35792663Li X, Liu B, Wang Y, Xiong W, Zhang Y, Bao D, Liang Y, Li L, Liu G, Jin X. The effects of laryngeal mask airway versus endotracheal tube on atelectasis in patients undergoing general anesthesia assessed by lung ultrasound: A protocol for a prospective, randomized controlled trial. PLoS One. 2022 Sep 9;17(9):e0273410. doi: 10.1371/journal.pone.0273410. eCollection 2022.
PubMed 36084154Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
PubMed 24662376
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Volume Controlled Versus Pressure Ventilation on Anesthesia Induced Lung Atelectasis in Pediatrics Using Laryngeal Mask Airway (LMA )During Cardiac Catheterization. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06076395
- Acronym / sponsor ID
- MS-96-2023
- Conditions
- Cardiac Congenital Defects
- Keywords
- pediatric cardiac catheterization, lung ultrasound score, lung atelectasis, LMA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 10 Oct 2023 (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 randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.
Detailed description
The initial US scanning will be done prior to the induction of anesthesia. Induction of anesthesia using 4% sevoflurane. Adequate size LMA will be inserted after adequate depth of anesthesia adjusted.
Group A (n=25): will receive pressure-controlled ventilation (PCV). Group B (n=25): will receive volume-controlled ventilation (VCV).
US scanning and Arterial blood gases at the following:
- T1(After maintenance of anesthesia).
- T2 (One minute after applying groin bandage and before extubation).
- T3 (10 minutes after extubation and resumption of adequate regular breathing).
- T4 (30 min post extubation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- For group A pressure control ventilation will be adjusted as follows: Inspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H 2 O and FiO2 at 0.5 providing that the maximum airway pressure will be limited to 25 cmH2O. For group B volume control ventilation will be adjusted as follows: tidal volume (VT) adjacent to 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and positive end expiratory pressure (PEEP)at 4 cmH2O and FiO2 at 0.5.
| Arm | Type | Receives |
|---|---|---|
| Group A pressure control ventilation | Experimental | Device: LMA (Laryngeal Mask Airway)Inspiratory pressure was adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O and FiO2 at 0.5 providing that the maximum airway pressure was limited to 25 cmH2O. |
| Group B volume control ventilation | Experimental | Device: LMA (Laryngeal Mask Airway)VT adjacent to 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and PEEP at 4 cm H2O and FiO2 at 0.5. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes.
Key exclusion criteria (10 listed)
- Lung score at different times.
- Age \<2 years and \>6 years.
- Preoperative mechanical ventilation.
- Heart failure (any inotropic support infusion).
- Patients with any lung diseases( acute respiratory disease, pulmonary or lung
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 |
|---|---|---|
| LMA (Laryngeal Mask Airway)Also: Lung UltrasoundPressure controlled versus Volume controlled ventilation using LMA | Device | Group A pressure control ventilation, Group B volume control ventilation |
Primary outcome
Post operative incidence of Lung atelectasis immediate post-removal of LMA.
Time frame: immediated post removal of LMA
calculate lung score using lung ultrasound
1 secondary outcome
Correlation between lung score and PaO2 /FiO2 ratio
Time frame: From the preoperative period (T0) to 30 minutes post-extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 12029240Hedenstierna G. Airway closure, atelectasis and gas exchange during anaesthesia. Minerva Anestesiol. 2002 May;68(5):332-6.
- Background: PubMed 34359177Stefanik E, Drewnowska O, Lisowska B, Turek B. Causes, Effects and Methods of Monitoring Gas Exchange Disturbances during Equine General Anaesthesia. Animals (Basel). 2021 Jul 9;11(7):2049. doi: 10.3390/ani11072049.
- Background: PubMed 30048331Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, Crimella F, Cressoni M, Mojoli F. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761-1768. doi: 10.1097/CCM.0000000000003340.
- Background: PubMed 35792663Rodriguez-Fanjul J, Corsini I, Orti CS, Bobillo-Perez S, Raimondi F. Lung ultrasound to evaluate lung recruitment in neonates with respiratory distress (RELUS study). Pediatr Pulmonol. 2022 Oct;57(10):2502-2510. doi: 10.1002/ppul.26066. Epub 2022 Jul 12.
- Background: PubMed 36084154Li X, Liu B, Wang Y, Xiong W, Zhang Y, Bao D, Liang Y, Li L, Liu G, Jin X. The effects of laryngeal mask airway versus endotracheal tube on atelectasis in patients undergoing general anesthesia assessed by lung ultrasound: A protocol for a prospective, randomized controlled trial. PLoS One. 2022 Sep 9;17(9):e0273410. doi: 10.1371/journal.pone.0273410. eCollection 2022.
- Background: PubMed 24662376Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
- Individual participant dataSharing planned: No
Related trials for Cardiac Congenital Defects
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Amel Hanfy Abo El- Ela principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA (Laryngeal Mask Airway) in people with Cardiac Congenital Defects, run by Kasr El Aini Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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?
Results are not available in the source record.
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 operative incidence of Lung atelectasis immediate post-removal of LMA. (time frame: immediated post removal of LMA). 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 NCT06076395, which also lists 6 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 17 Jan 2024.