AtelectasisAtelectLUSNCT06069414
Atelectasis After Inhalation or Intravenous Induction in Pediatric Anesthesia
An observational study of Atelectasis and Pediatric Anesthesia, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial summary
Children have a highly compliant chest wall and atelectasis formation occurs often during pediatric anesthesia. Inhalation induction is commonly performed in pediatric anesthesia but it is still unclear if this can have an effect on the development of atelectasis. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Atelectasis, Pediatric Anesthesia
- What is being tested?
- Type of anesthesia induction
- Type of treatment
- Injection or infusion
- How many people
- 326 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to 1 Nov 2023
- 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
- No healthy volunteers
- Child, Adult
Study population: Children under 18 years of age scheduled for general anesthesia due to surgery.
Who may be able to join
- scheduled for elective surgery under general anesthesia
- parental consent
Who cannot join
- American Society of Anesthesiologists (ASA) physical status III-VI
- neuromuscular disease
- chronic lung disease
- cardiopathy
- thoracic cage malformations
- chronic home ventilation (either invasive or non-invasive)
Show all 9Show fewer
- positive history of foreign body inhalation
- required immediate life-saving procedures
- lack of parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atelectasis Evaluated With Lung Ultrasound After Inhalation or Intravenous Induction in Pediatric Anesthesia: a Prospective, Observational, Propensity Scored Matched Study
Children have a highly compliant chest wall and atelectasis formation occurs often during pediatric anesthesia. Inhalation induction is commonly performed in pediatric anesthesia but it is still unclear if this can have an effect on the development of atelectasis. Aim of this study is to investigate the impact of inhalation versus intravenous induction on atelectasis formation during anesthesia induction in children. Atelectasis will be evaluated with lung ultrasound before induction and right after induction.
Read the detailed description
Respiratory complications, among which atelectasis, are a common cause of adverse events in pediatric anesthesia. Lung ultrasound (LUS) examination is a point of care, non-invasive, radiation-free tool with high sensitivity and specificity for the identification of anesthesia-induced atelectasis in children.
Inhalation induction is commonly performed in pediatric anesthesia to avoid pain at venipuncture or to facilitate vein cannulation. This technique has been associated with a higher rate of respiratory adverse events but no study has investigated the role of inhalation or intravenous induction on lung atelectasis development in pediatric anesthesia.
The investigators will perform this study aiming to describe the impact of inhalation versus intravenous induction technique on atelectasis formation during anesthesia induction in children of different ages.
- Conditions
- Atelectasis, Pediatric Anesthesia
- Being tested
- Type of anesthesia induction
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of anesthesia inductionOther
Patients will receive inhalatory or intravenous anesthesia at their choice; both groups will be evaluated with lung ultrasound after induction to detect ultrasonografic signs of atelectasis
| Study group | Role | What they receive |
|---|---|---|
| Inhalatory induction | Patients who will be induced via mask with inhalators anesthetic gases Receives: Other: Type of anesthesia induction | |
| Intravenous induction | Patients who will be induced with intravenous anesthetics Receives: Other: Type of anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global LUS score
Sum of the LUS scores given to all the lung areas. Score points vary from 0 to 3, where 0 means normality of the lung and 3 refers to complete loss of aeration-tissue-like pattern or consolidation.
Measured: Upon completion of induction and subsequent controls at end of surgery and 1 postoperative day
Signs of atelectasis
Number of lung areas presenting a sub pleural consolidation
Measured: Upon completion of induction and and subsequent controls at end of surgery and 1 postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vittore Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Camporesi, Vittore Buzzi Children's Hospital
- Investigators
- Anna Camporesi, M.D., Study director, Vittore Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069414
- Sponsor's protocol ID
- 2022/ST/147
- Acronym
- AtelectLUS
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sargent MA, McEachern AM, Jamieson DH, Kahwaji R. Atelectasis on pediatric chest CT: comparison of sedation techniques. Pediatr Radiol. 1999 Jul;29(7):509-13. doi: 10.1007/s002470050632.
PubMed 10398785Acosta 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 24662376Zeng C, Lagier D, Lee JW, Vidal Melo MF. Perioperative Pulmonary Atelectasis: Part I. Biology and Mechanisms. Anesthesiology. 2022 Jan 1;136(1):181-205. doi: 10.1097/ALN.0000000000003943.
PubMed 34499087Adler AC, Siddiqui A, Chandrakantan A, Matava CT. Lung and airway ultrasound in pediatric anesthesia. Paediatr Anaesth. 2022 Feb;32(2):202-208. doi: 10.1111/pan.14337. Epub 2021 Dec 1.
PubMed 34797019de Graaff JC, Bijker JB, Kappen TH, van Wolfswinkel L, Zuithoff NP, Kalkman CJ. Incidence of intraoperative hypoxemia in children in relation to age. Anesth Analg. 2013 Jul;117(1):169-75. doi: 10.1213/ANE.0b013e31829332b5. Epub 2013 May 17.
PubMed 23687233Camporesi A, Roveri G, Vetrugno L, Buonsenso D, De Giorgis V, Costanzo S, Pierucci UM, Pelizzo G. Lung ultrasound assessment of atelectasis following different anesthesia induction techniques in pediatric patients: a propensity score-matched, observational study. J Anesth Analg Crit Care. 2024 Oct 5;4(1):69. doi: 10.1186/s44158-024-00206-x.
PubMed 39369249
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atelectasis Evaluated With Lung Ultrasound After Inhalation or Intravenous Induction in Pediatric Anesthesia: a Prospective, Observational, Propensity Scored Matched Study
- ClinicalTrials.gov ID
- NCT06069414
- Acronym / sponsor ID
- AtelectLUS / 2022/ST/147
- Conditions
- Atelectasis, Pediatric Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 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.
Children have a highly compliant chest wall and atelectasis formation occurs often during pediatric anesthesia. Inhalation induction is commonly performed in pediatric anesthesia but it is still unclear if this can have an effect on the development of atelectasis. Aim of this study is to investigate the impact of inhalation versus intravenous induction on atelectasis formation during anesthesia induction in children. Atelectasis will be evaluated with lung ultrasound before induction and right after induction.
Detailed description
Respiratory complications, among which atelectasis, are a common cause of adverse events in pediatric anesthesia. Lung ultrasound (LUS) examination is a point of care, non-invasive, radiation-free tool with high sensitivity and specificity for the identification of anesthesia-induced atelectasis in children.
Inhalation induction is commonly performed in pediatric anesthesia to avoid pain at venipuncture or to facilitate vein cannulation. This technique has been associated with a higher rate of respiratory adverse events but no study has investigated the role of inhalation or intravenous induction on lung atelectasis development in pediatric anesthesia.
The investigators will perform this study aiming to describe the impact of inhalation versus intravenous induction technique on atelectasis formation during anesthesia induction in children of different ages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalatory induction | – | Other: Type of anesthesia inductionPatients who will be induced via mask with inhalators anesthetic gases |
| Intravenous induction | – | Other: Type of anesthesia inductionPatients who will be induced with intravenous anesthetics |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 years of age scheduled for general anesthesia due to surgery.
Key inclusion criteria (2 listed)
- scheduled for elective surgery under general anesthesia
- parental consent
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists (ASA) physical status III-VI
- neuromuscular disease
- chronic lung disease
- cardiopathy
- thoracic cage malformations
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 |
|---|---|---|
| Type of anesthesia inductionPatients will receive inhalatory or intravenous anesthesia at their choice; both groups will be evaluated with lung ultrasound after induction to detect ultrasonografic signs of atelectasis | Other | Inhalatory induction, Intravenous induction |
Primary outcome
Global LUS score
Time frame: Upon completion of induction and subsequent controls at end of surgery and 1 postoperative day
Sum of the LUS scores given to all the lung areas. Score points vary from 0 to 3, where 0 means normality of the lung and 3 refers to complete loss of aeration-tissue-like pattern or consolidation.
Signs of atelectasis
Time frame: Upon completion of induction and and subsequent controls at end of surgery and 1 postoperative day
Number of lung areas presenting a sub pleural consolidation
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 17 Apr 2024.
- Background: PubMed 10398785Sargent MA, McEachern AM, Jamieson DH, Kahwaji R. Atelectasis on pediatric chest CT: comparison of sedation techniques. Pediatr Radiol. 1999 Jul;29(7):509-13. doi: 10.1007/s002470050632.
- 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 34499087Zeng C, Lagier D, Lee JW, Vidal Melo MF. Perioperative Pulmonary Atelectasis: Part I. Biology and Mechanisms. Anesthesiology. 2022 Jan 1;136(1):181-205. doi: 10.1097/ALN.0000000000003943.
- Background: PubMed 34797019Adler AC, Siddiqui A, Chandrakantan A, Matava CT. Lung and airway ultrasound in pediatric anesthesia. Paediatr Anaesth. 2022 Feb;32(2):202-208. doi: 10.1111/pan.14337. Epub 2021 Dec 1.
- Results publication: PubMed 23687233de Graaff JC, Bijker JB, Kappen TH, van Wolfswinkel L, Zuithoff NP, Kalkman CJ. Incidence of intraoperative hypoxemia in children in relation to age. Anesth Analg. 2013 Jul;117(1):169-75. doi: 10.1213/ANE.0b013e31829332b5. Epub 2013 May 17.
- Derived from this study: PubMed 39369249Camporesi A, Roveri G, Vetrugno L, Buonsenso D, De Giorgis V, Costanzo S, Pierucci UM, Pelizzo G. Lung ultrasound assessment of atelectasis following different anesthesia induction techniques in pediatric patients: a propensity score-matched, observational study. J Anesth Analg Crit Care. 2024 Oct 5;4(1):69. doi: 10.1186/s44158-024-00206-x.
- 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.
Anna Camporesi, M.D. study director
Vittore Buzzi Children's Hospital
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 Pediatric Anesthesia, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
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 2 inclusion and 9 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 17 Apr 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 Italy. 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?
Global LUS score (time frame: Upon completion of induction and subsequent controls at end of surgery and 1 postoperative day). The study lists 2 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 NCT06069414, 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 Apr 2024.