AtelectasisNCT06214312
Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway.
An observational study of Atelectasis and Hypoxemia, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. Read more about this study
- Who is it for?
- Ages 1 year to 8 years, men only
- Conditions the study is for
- Atelectasis, Hypoxemia
- What is being tested?
- Lung Ultrasounds
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2024to 23 Jun 2024
- 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 1 year to 8 years
- Men only
- No healthy volunteers
- Child
Study population: Children aged between 12 months and 8 years scheduled for minor urologic surgery under general anesthesia.
Who may be able to join
- fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air >96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.
Who cannot join
- ASA score > II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway: a Randomized Double-Blinded Controlled Trial That Compares Spontaneous and Pressure Support Ventilation
This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.
Read the detailed description
It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.
Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.
- Conditions
- Atelectasis, Hypoxemia
- Being tested
- Lung Ultrasounds
- Keywords
- lung ultrasounds, laryngeal mask airway, anesthetized children, spontaneous ventilation, pressure support ventilation, positive end expiratory pressure
- Medical subject headings
- Pulmonary Atelectasis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundsDiagnostic test
An ultrasound exam of the lungs to identify possible areas of atelectasis.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous ventilation | Anesthetized Children ventilated with a laryngeal mask airway in spontaneous ventilation with a positive end expiratory pressure of 5cmH2O. Receives: Diagnostic Test: Lung Ultrasounds | |
| Pressure support ventilation | Anesthetized Children ventilated with a laryngeal mask airway in pressure support ventilation with a positive end expiratory pressure of 5cmH2O, maximum pressure not exceeding 15cmH2O. Receives: Diagnostic Test: Lung Ultrasounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary aeration
Compare the Lung Aeration Score in the two groups
Measured: during surgery and in the immediate postoperative period
Secondary outcomes (2)
Plethysmography
Correlation between Lung Aeration Score and Plethysmography
Measured: during surgery and in the immediate postoperative period.
Ventilatory parameters
Correlation between Lung Aeration Score and Ventilatory parameters
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Jan 2024
- Primary completion30 Apr 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Carini, MD, Principal investigator, Resident in Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214312
- Sponsor's protocol ID
- B0762023231006
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acosta 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 24662376Acosta CM, Lopez Vargas MP, Oropel F, Valente L, Ricci L, Natal M, Suarez Sipmann F, Tusman G. Prevention of atelectasis by continuous positive airway pressure in anaesthetised children: A randomised controlled study. Eur J Anaesthesiol. 2021 Jan;38(1):41-48. doi: 10.1097/EJA.0000000000001351.
PubMed 33009190Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551.
PubMed 33096743Joshi P, Vasishta A, Gupta M. Ultrasound of the pediatric chest. Br J Radiol. 2019 Aug;92(1100):20190058. doi: 10.1259/bjr.20190058. Epub 2019 May 16.
PubMed 31095416Templeton TW, Hoke LK, Templeton LB, Ririe DG, Rose DM, Bryan YF. Comparing 3 ventilation modalities by measuring several respiratory parameters using the ProSeal laryngeal mask airway in children. Journal of Clinical Anesthesia 2016 Dec; 35: 502-508. DOI: 10.1016/j.jclinane.2016.07.042. Epub 2016 Oct 10. PMID: 27871584 Clinical Trial.
Lim B, Pawar D, Ng O. Pressure support ventilation vs spontaneous ventilation via ProSeal laryngeal mask airway in pediatric patients undergoing ambulatory surgery: a randomized controlled trial. Paediatr Anaesth. 2012 Apr;22(4):360-4. doi: 10.1111/j.1460-9592.2012.03819.x.
PubMed 22380745von Goedecke A, Brimacombe J, Keller C, Hoermann C, Loeckinger A, Rieder J, Kleinsasser A. Positive pressure versus pressure support ventilation at different levels of PEEP using the ProSeal laryngeal mask airway. Anaesth Intensive Care. 2004 Dec;32(6):804-8. doi: 10.1177/0310057X0403200612.
PubMed 15648991
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway: a Randomized Double-Blinded Controlled Trial That Compares Spontaneous and Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT06214312
- Acronym / sponsor ID
- B0762023231006
- Conditions
- Atelectasis, Hypoxemia
- Keywords
- lung ultrasounds, laryngeal mask airway, anesthetized children, spontaneous ventilation, pressure support ventilation, positive end expiratory pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 19 Jan 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.
This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.
Detailed description
It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.
Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous ventilation | – | Diagnostic Test: Lung UltrasoundsAnesthetized Children ventilated with a laryngeal mask airway in spontaneous ventilation with a positive end expiratory pressure of 5cmH2O. |
| Pressure support ventilation | – | Diagnostic Test: Lung UltrasoundsAnesthetized Children ventilated with a laryngeal mask airway in pressure support ventilation with a positive end expiratory pressure of 5cmH2O, maximum pressure not exceeding 15cmH2O. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 12 months and 8 years scheduled for minor urologic surgery under general anesthesia.
Key inclusion criteria (1 listed)
- fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air >96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.
Key exclusion criteria (1 listed)
- ASA score > II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.
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 |
|---|---|---|
| Lung UltrasoundsAn ultrasound exam of the lungs to identify possible areas of atelectasis. | Diagnostic test | Pressure support ventilation, Spontaneous ventilation |
Primary outcome
Pulmonary aeration
Time frame: during surgery and in the immediate postoperative period
Compare the Lung Aeration Score in the two groups
2 secondary outcomes
Plethysmography
Time frame: during surgery and in the immediate postoperative period.
Ventilatory parameters
Time frame: during surgery
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 13 Feb 2025.
- 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.
- Background: PubMed 33009190Acosta CM, Lopez Vargas MP, Oropel F, Valente L, Ricci L, Natal M, Suarez Sipmann F, Tusman G. Prevention of atelectasis by continuous positive airway pressure in anaesthetised children: A randomised controlled study. Eur J Anaesthesiol. 2021 Jan;38(1):41-48. doi: 10.1097/EJA.0000000000001351.
- Background: PubMed 33096743Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551.
- Background: PubMed 31095416Joshi P, Vasishta A, Gupta M. Ultrasound of the pediatric chest. Br J Radiol. 2019 Aug;92(1100):20190058. doi: 10.1259/bjr.20190058. Epub 2019 May 16.
- BackgroundTempleton TW, Hoke LK, Templeton LB, Ririe DG, Rose DM, Bryan YF. Comparing 3 ventilation modalities by measuring several respiratory parameters using the ProSeal laryngeal mask airway in children. Journal of Clinical Anesthesia 2016 Dec; 35: 502-508. DOI: 10.1016/j.jclinane.2016.07.042. Epub 2016 Oct 10. PMID: 27871584 Clinical Trial.
- Background: PubMed 22380745Lim B, Pawar D, Ng O. Pressure support ventilation vs spontaneous ventilation via ProSeal laryngeal mask airway in pediatric patients undergoing ambulatory surgery: a randomized controlled trial. Paediatr Anaesth. 2012 Apr;22(4):360-4. doi: 10.1111/j.1460-9592.2012.03819.x.
- Background: PubMed 15648991von Goedecke A, Brimacombe J, Keller C, Hoermann C, Loeckinger A, Rieder J, Kleinsasser A. Positive pressure versus pressure support ventilation at different levels of PEEP using the ProSeal laryngeal mask airway. Anaesth Intensive Care. 2004 Dec;32(6):804-8. doi: 10.1177/0310057X0403200612.
- 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.
Andrea Carini, MD principal investigator
Resident in Anesthesiology
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 Atelectasis and Hypoxemia, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 13 Feb 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 Belgium. 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?
Pulmonary aeration (time frame: during surgery and in the immediate postoperative period). 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 NCT06214312, which also lists 7 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 13 Feb 2025.