Anesthesia, PediatricEIT_pedNCT06262360
Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia
A study testing General anesthesia with mask ventilation, General anesthesia and spontaneous laryngeal mask ventilation and General anesthesia with spontaneous laryngeal mask ventilation with pressure support in people with Anesthesia, Pediatric, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial summary
The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Anesthesia, Pediatric
- What is being tested?
- General anesthesia with mask ventilation, General anesthesia and spontaneous laryngeal mask ventilation and General anesthesia with spontaneous laryngeal mask ventilation with pressure support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2024to 30 Sep 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing elective circumcision
- Age 1 to 6 years
- ASA class I or II
Who cannot join
- Any history of lung diseases, congenital heart diseases or abdominal diseases that could interfere with lungs dynamic.
- ASA physical status11 > II.
- Patients whose weight is less than 10 kg.
- The use of Jackson-Rees device12.
- Contraindication for premedication.
- Contraindication for mask ventilation or laryngeal mask ventilation13.
Show all 15Show fewer
- Contraindication for regional anesthesia.
- Need for opioids administration during surgery.
- Patients with uncontrollable movements of the body.
- Inability of parents/tutors to understand French or Dutch.
- Patients whose parents do not agree with their participation in the study
- Patients with thoracic perimeters (between 4th and 6th ribs) less than 37.5 cm (minimal size for the pediatric EIT belt) or more than 72 cm (maximal size for the pediatric EIT belt)
- Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings.
- Patients with spinal lesions or fractures (acute or recent)
- Patients with pacemaker, defibrillators, or other electrically active implants
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
H.U.B - Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020
Denis Schmartz, MD, +3225553919, denis.schmartz@hubruxelles.be
About this study
Official title: Changes in Pulmonary Ventilation Distribution Assessed by EIT (Electrical Impedance Tomography) in Healthy Children Under General Anesthesia; a Pilot Study Comparing Mask Spontaneous Breathing and Laryngeal Mask Spontaneous Breathing With and Without Ventilatory Support
The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.
Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).
Read more
Patients will be allocated to three different group in a ration of 1:1:1.
- Group 1: spontaneous mask ventilation (20 patients).
- Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
- Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
- Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).
Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).
Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).
Electrical impedance tomography measurements:
The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.
The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.
A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.
The EIT measurements will be taken of 4 different moments:
T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).
T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.
T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.
T4: Before the discharge of the PACU.
- Conditions
- Anesthesia, Pediatric
- Being tested
- General anesthesia with mask ventilation, General anesthesia and spontaneous laryngeal mask ventilation, General anesthesia with spontaneous laryngeal mask ventilation with pressure support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia with mask ventilationProcedure or surgery
Randomization to General anesthesia with mask ventilation
General anesthesia and spontaneous laryngeal mask ventilationProcedure or surgery
Randomization to General anesthesia and spontaneous laryngeal mask ventilation
General anesthesia with spontaneous laryngeal mask ventilation with pressure supportProcedure or surgery
Randomization to General anesthesia with spontaneous laryngeal mask ventilation with pressure support
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia with spontaneous mask ventilation | Experimental | Patients under general anesthesia with spontaneous mask ventilation Receives: Procedure: General anesthesia with mask ventilation |
| General anesthesia and spontaneous laryngeal mask ventilation | Experimental | Patients under general anesthesia and spontaneous laryngeal mask ventilation Receives: Procedure: General anesthesia and spontaneous laryngeal mask ventilation |
| General anesthesia with spontaneous laryngeal mask ventilation with pressure support | Experimental | Patients under general anesthesia with spontaneous laryngeal mask ventilation with pressure support Receives: Procedure: General anesthesia with spontaneous laryngeal mask ventilation with pressure support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of poorly ventilated pulmonary zones
Primary outcome will be the variation of poorly ventilated zones between period T1 (before induction of anesthesia) and period T2 (at the discharge from the PACU) that we may surrogate as atelectasis. The Pulmovista device divides the lungs in 4 areas (front to back in a supine patient) and the percentage of ventilation going to each area is measure by electric impedance variation. The difference in the distribution between the 4 areas will be measured (expressed as % of total ventilation).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start16 Feb 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, PediatricStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262360
- Sponsor's protocol ID
- P2023457
- Acronym
- EIT_ped
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nascimento MS, Rebello CM, Costa ELV, Correa LC, Alcala GC, Rossi FS, Morais CCA, Laurenti E, Camara MC, Iasi M, Apezzato MLP, do Prado C, Amato MBP. Effect of general anesthesia and controlled mechanical ventilation on pulmonary ventilation distribution assessed by electrical impedance tomography in healthy children. PLoS One. 2023 Mar 16;18(3):e0283039. doi: 10.1371/journal.pone.0283039. eCollection 2023.
PubMed 36928465Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.
PubMed 37046213Ji SH, Jang HS, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1150-1156. doi: 10.1097/EJA.0000000000001327.
PubMed 33009186Durlak W, Kwinta P. Role of electrical impedance tomography in clinical practice in pediatric respiratory medicine. ISRN Pediatr. 2013 Dec 25;2013:529038. doi: 10.1155/2013/529038. eCollection 2013 Dec 25.
PubMed 24455294Li 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 36084154Riva T, Pascolo F, Huber M, Theiler L, Greif R, Disma N, Fuchs A, Berger-Estilita J, Riedel T. Evaluation of atelectasis using electrical impedance tomography during procedural deep sedation for MRI in small children: A prospective observational trial. J Clin Anesth. 2022 May;77:110626. doi: 10.1016/j.jclinane.2021.110626. Epub 2021 Dec 10.
PubMed 34902800Froessler B, Brommundt J, Anton J, Khanduja R, Kuhlen R, Rossaint R, Coburn M. Spontaneously breathing anesthetized patients with a laryngeal mask airway: positive end-expiratory pressure does not improve oxygen saturation. Anaesthesist. 2010 Nov;59(11):1003-4, 1006-7. doi: 10.1007/s00101-010-1764-0. Epub 2010 Sep 11.
PubMed 20835692Trachsel D, Svendsen J, Erb TO, von Ungern-Sternberg BS. Effects of anaesthesia on paediatric lung function. Br J Anaesth. 2016 Aug;117(2):151-63. doi: 10.1093/bja/aew173.
PubMed 27440626Humphreys S, Pham TM, Stocker C, Schibler A. The effect of induction of anesthesia and intubation on end-expiratory lung level and regional ventilation distribution in cardiac children. Paediatr Anaesth. 2011 Aug;21(8):887-93. doi: 10.1111/j.1460-9592.2011.03547.x. Epub 2011 Mar 14.
PubMed 21395895Nascimento MS, Rebello CM, Costa ELV, Rossi FS, do Prado C, Amato MBP. Pulmonary Aeration and Posterior Collapse Assessed by Electrical Impedance Tomography in Healthy Children: Contribution of Anesthesia and Controlled Mechanical Ventilation. Anesthesiology. 2022 Nov 1;137(5):648-650. doi: 10.1097/ALN.0000000000004321. No abstract available.
PubMed 35930425Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7.
PubMed 31390977Radke OC, Schneider T, Heller AR, Koch T. Spontaneous breathing during general anesthesia prevents the ventral redistribution of ventilation as detected by electrical impedance tomography: a randomized trial. Anesthesiology. 2012 Jun;116(6):1227-34. doi: 10.1097/ALN.0b013e318256ee08.
PubMed 22531334Hochhausen N, Kapell T, Durbaum M, Follmann A, Rossaint R, Czaplik M. Monitoring postoperative lung recovery using electrical impedance tomography in post anesthesia care unit: an observational study. J Clin Monit Comput. 2022 Aug;36(4):1205-1212. doi: 10.1007/s10877-021-00754-5. Epub 2021 Sep 20.
PubMed 34542735Wang Y, Xu H, Li H, Cheng B, Fang X. Lung aeration and ventilation after general anesthesia in left lateral position: a prospective observational study using electrical impedance tomography. Ann Palliat Med. 2021 Feb;10(2):1285-1295. doi: 10.21037/apm-20-1029. Epub 2020 Oct 9.
PubMed 33040550Brabant O, Crivellari B, Hosgood G, Raisis A, Waldmann AD, Auer U, Adler A, Smart L, Laurence M, Mosing M. Effects of PEEP on the relationship between tidal volume and total impedance change measured via electrical impedance tomography (EIT). J Clin Monit Comput. 2022 Apr;36(2):325-334. doi: 10.1007/s10877-021-00651-x. Epub 2021 Jan 25.
PubMed 33492490
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pulmonary Ventilation Distribution Assessed by EIT (Electrical Impedance Tomography) in Healthy Children Under General Anesthesia; a Pilot Study Comparing Mask Spontaneous Breathing and Laryngeal Mask Spontaneous Breathing With and Without Ventilatory Support
- ClinicalTrials.gov ID
- NCT06262360
- Acronym / sponsor ID
- EIT_ped / P2023457
- Conditions
- Anesthesia, Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 16 Feb 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 incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.
Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).
Patients will be allocated to three different group in a ration of 1:1:1.
- Group 1: spontaneous mask ventilation (20 patients).
- Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
- Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
- Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).
Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).
Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).
Electrical impedance tomography measurements:
The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.
The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.
A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.
The EIT measurements will be taken of 4 different moments:
T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).
T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.
T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.
T4: Before the discharge of the PACU.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia with spontaneous mask ventilation | Experimental | Procedure: General anesthesia with mask ventilationPatients under general anesthesia with spontaneous mask ventilation |
| General anesthesia and spontaneous laryngeal mask ventilation | Experimental | Procedure: General anesthesia and spontaneous laryngeal mask ventilationPatients under general anesthesia and spontaneous laryngeal mask ventilation |
| General anesthesia with spontaneous laryngeal mask ventilation with pressure support | Experimental | Procedure: General anesthesia with spontaneous laryngeal mask ventilation with pressure supportPatients under general anesthesia with spontaneous laryngeal mask ventilation with pressure support |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children undergoing elective circumcision
- Age 1 to 6 years
- ASA class I or II
Key exclusion criteria (15 listed)
- Any history of lung diseases, congenital heart diseases or abdominal diseases that could interfere with lungs dynamic.
- ASA physical status11 > II.
- Patients whose weight is less than 10 kg.
- The use of Jackson-Rees device12.
- Contraindication for premedication.
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 |
|---|---|---|
| General anesthesia with mask ventilationRandomization to General anesthesia with mask ventilation | Procedure or surgery | General anesthesia with spontaneous mask ventilation |
| General anesthesia and spontaneous laryngeal mask ventilationRandomization to General anesthesia and spontaneous laryngeal mask ventilation | Procedure or surgery | General anesthesia and spontaneous laryngeal mask ventilation |
| General anesthesia with spontaneous laryngeal mask ventilation with pressure supportRandomization to General anesthesia with spontaneous laryngeal mask ventilation with pressure support | Procedure or surgery | General anesthesia with spontaneous laryngeal mask ventilation with pressure support |
Primary outcome
Variation of poorly ventilated pulmonary zones
Time frame: 4 hours
Primary outcome will be the variation of poorly ventilated zones between period T1 (before induction of anesthesia) and period T2 (at the discharge from the PACU) that we may surrogate as atelectasis. The Pulmovista device divides the lungs in 4 areas (front to back in a supine patient) and the percentage of ventilation going to each area is measure by electric impedance variation. The difference in the distribution between the 4 areas will be measured (expressed as % of total ventilation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 36928465Nascimento MS, Rebello CM, Costa ELV, Correa LC, Alcala GC, Rossi FS, Morais CCA, Laurenti E, Camara MC, Iasi M, Apezzato MLP, do Prado C, Amato MBP. Effect of general anesthesia and controlled mechanical ventilation on pulmonary ventilation distribution assessed by electrical impedance tomography in healthy children. PLoS One. 2023 Mar 16;18(3):e0283039. doi: 10.1371/journal.pone.0283039. eCollection 2023.
- Background: PubMed 37046213Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.
- Background: PubMed 33009186Ji SH, Jang HS, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1150-1156. doi: 10.1097/EJA.0000000000001327.
- Background: PubMed 24455294Durlak W, Kwinta P. Role of electrical impedance tomography in clinical practice in pediatric respiratory medicine. ISRN Pediatr. 2013 Dec 25;2013:529038. doi: 10.1155/2013/529038. eCollection 2013 Dec 25.
- 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 34902800Riva T, Pascolo F, Huber M, Theiler L, Greif R, Disma N, Fuchs A, Berger-Estilita J, Riedel T. Evaluation of atelectasis using electrical impedance tomography during procedural deep sedation for MRI in small children: A prospective observational trial. J Clin Anesth. 2022 May;77:110626. doi: 10.1016/j.jclinane.2021.110626. Epub 2021 Dec 10.
- Background: PubMed 20835692Froessler B, Brommundt J, Anton J, Khanduja R, Kuhlen R, Rossaint R, Coburn M. Spontaneously breathing anesthetized patients with a laryngeal mask airway: positive end-expiratory pressure does not improve oxygen saturation. Anaesthesist. 2010 Nov;59(11):1003-4, 1006-7. doi: 10.1007/s00101-010-1764-0. Epub 2010 Sep 11.
- Background: PubMed 27440626Trachsel D, Svendsen J, Erb TO, von Ungern-Sternberg BS. Effects of anaesthesia on paediatric lung function. Br J Anaesth. 2016 Aug;117(2):151-63. doi: 10.1093/bja/aew173.
- Background: PubMed 21395895Humphreys S, Pham TM, Stocker C, Schibler A. The effect of induction of anesthesia and intubation on end-expiratory lung level and regional ventilation distribution in cardiac children. Paediatr Anaesth. 2011 Aug;21(8):887-93. doi: 10.1111/j.1460-9592.2011.03547.x. Epub 2011 Mar 14.
- Background: PubMed 35930425Nascimento MS, Rebello CM, Costa ELV, Rossi FS, do Prado C, Amato MBP. Pulmonary Aeration and Posterior Collapse Assessed by Electrical Impedance Tomography in Healthy Children: Contribution of Anesthesia and Controlled Mechanical Ventilation. Anesthesiology. 2022 Nov 1;137(5):648-650. doi: 10.1097/ALN.0000000000004321. No abstract available.
- Background: PubMed 31390977Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7.
- Background: PubMed 22531334Radke OC, Schneider T, Heller AR, Koch T. Spontaneous breathing during general anesthesia prevents the ventral redistribution of ventilation as detected by electrical impedance tomography: a randomized trial. Anesthesiology. 2012 Jun;116(6):1227-34. doi: 10.1097/ALN.0b013e318256ee08.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Pediatric
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruitingPhase 4
Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery
Adolescent Idiopathic Scoliosis (AIS)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia with mask ventilation, General anesthesia and spontaneous laryngeal mask ventilation and General anesthesia with spontaneous laryngeal mask ventilation with pressure support in people with Anesthesia, Pediatric, run by Queen Fabiola Children's University Hospital 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 3 inclusion and 15 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 21 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (+3225553919, denis.schmartz@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of poorly ventilated pulmonary zones (time frame: 4 hours). 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 NCT06262360, which also lists 15 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 21 Feb 2024.