Sedative Adverse ReactionLunSedNCT03392012
Effect of Sedation on Pulmonary Aeration in Children
An observational study of Sedative Adverse Reaction, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Pediatric sedation is an anesthesiological technique with a good safety profile, but various complications might ensure, especially from the respiratory point of view. No suggestion is available about a possible upper safety limit for the duration of sedation to limit respiratory issue. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Sedative Adverse Reaction
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 6 Feb 2018to 30 Dec 2018
- 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
- All sexes
- No healthy volunteers
- Child
Study population: children scheduled to undergo cerebral or medullary magnetic resonance imaging under deep sedation
Who may be able to join
- Children 1-8 years old (included)
- Informed consent of both parents
- Scheduled for elective cerebral or medullary Magnetic Resonance exam
Who cannot join
- Any ongoing respiratory disease
- Contraindications to the use of propofol
- LUSS ≤12 at the first US assessment (a baseline maximum score 1 on all of the pulmonary fields)
- need for mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
S. Raffaele Hospital
Milan, MI, 20132
Marco Gemma, MD, ++390226432656, gemma.marco@hsr.it
About this study
Pediatric sedation is an anesthesiological technique with a good safety profile, but various complications might ensure, especially from the respiratory point of view. No suggestion is available about a possible upper safety limit for the duration of sedation to limit respiratory issue. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. The investigators hypothesis that the length of sedation is correlated with the occurrence of lung atelectasis and hypoventilation. To assess lung hypoventilation the lung ultrasound will be used. Lung ultrasound will be performed immediately after the induction of sedation and immediately before sedation interruption, in children scheduled for magnetic resonance exams.
The study is a prospective observational study
Read the detailed description
Worldwide, an increasing number of medical procedures are performer in children under sedation in many different clinical settings, in compromised patients, often outside the operating theater and often by non-anesthesiologists.
Although a good safety profile accounts for the spread of sedation, various complications might ensure. Furthermore of all the patients receiving sedation for diagnostic and therapeutic procedures, the pediatric population is the subgroup at the highest risk level and with the lowest tolerance of error.
In the last years the results of two large database studies have been published to lend some clarity on the rate and nature of adverse events involving sedation/anesthesia outside the operating room. Respiratory complications were the most frequently reported, and required critical anesthesiological competencies for a correct management to avoid poor outcomes.
Risk factors for adverse events during sedation/anesthesia have been evaluated by the 2016 SIAARTI(Società Italiana di Anestesia, Analgesia, Rianimazione e Terapia Intensiva)-SARNePI (Società di Anestesia e Rianimazione Neonatale e Pediatrica Italiana) guidelines for the standard of pediatric anesthesia, including patients' age, ASA (American Society of Anesthesiology) class, experience of the operators, and urgency/emergency conditions.
On the other hand, no suggestion is available either in current literature or guidelines, about a possible upper safety limit for the duration of sedation. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. To assess lung hypoventilation the LUSS-Lung Ultrasound Score will be used, since it is a validated and non invasive tool.
The study aims to assess the incidence of atelectasis and hypoventilated lung areas after sedation in children and evaluating possible risk factors for them. The investigators hypothesis that the length of sedation is correlated with the occurrence of lung atelectasis and hypoventilation.
This prospective observational cohort study study could suggest an upper safety limit for the duration of pediatric sedations, which is not reported in the available literature.
Consecutive children (age 1-8 yrs old) scheduled to undergo cerebral or medullary magnetic resonance imaging under deep sedation will be enrolled. In the investigators' center such MR imaging data acquisition (and the relevant sedation) ranges usually between 40 and 120 minutes. Enrollment will take place on the day of sedation.
Informed consent will be obtained from both parents at the preoperative visit or the day of the procedure.
The children will be sedated with propofol iv according to a standard clinical protocol and spontaneous breathing will be maintained throughout the study. The standard protocol has been internally validated both in the clinical and scientific setting.
Immediately after the induction of sedation, lung ultrasound will be performed and the imaging will be scored according to the lung ultrasound score(LUSS). Thereafter the child will be transferred into the magnetic resonance (MR) suite and the MR exam will be performed as required. After completion of MR imaging child will be transferred back to the recovery room and the sonographer will re- assess the LUSS before the discontinuation of sedation. Hence, two lung ultrasound evaluations will be performed: one at the beginning and one at the end of sedation.
- Conditions
- Sedative Adverse Reaction
- Keywords
- anesthesia, patient safety, respiratory complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Lung Ultrasound Score in children undergoing deep sedation
Lung ultrasound score
Measured: through study completion, an average of 1 hour
Secondary outcomes (2)
Effect of sedation length on hypoventilation in children undergoing deep sedation
Sedation length (min)
Measured: through study completion, an average of 1 hour
Incidence of any respiratory and non-respiratory adverse event in children undergoing deep sedation
Clinical observation
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start6 Feb 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative Adverse ReactionStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Gemma, IRCCS San Raffaele
- Investigators
- Marco Gemma, MD, Study chair, IRCCS San Raffaele, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392012
- Sponsor's protocol ID
- 140/INT/2017
- Acronym
- LunSed
- Status last verified
- Feb 2018
- First submitted
- 18 Dec 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sedation on Pulmonary Aeration in Children
- ClinicalTrials.gov ID
- NCT03392012
- Acronym / sponsor ID
- LunSed / 140/INT/2017
- Conditions
- Sedative Adverse Reaction
- Keywords
- anesthesia, patient safety, respiratory complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 5 Jan 2018 (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.
Pediatric sedation is an anesthesiological technique with a good safety profile, but various complications might ensure, especially from the respiratory point of view. No suggestion is available about a possible upper safety limit for the duration of sedation to limit respiratory issue. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. The investigators hypothesis that the length of sedation is correlated with the occurrence of lung atelectasis and hypoventilation. To assess lung hypoventilation the lung ultrasound will be used. Lung ultrasound will be performed immediately after the induction of sedation and immediately before sedation interruption, in children scheduled for magnetic resonance exams.
The study is a prospective observational study
Detailed description
Worldwide, an increasing number of medical procedures are performer in children under sedation in many different clinical settings, in compromised patients, often outside the operating theater and often by non-anesthesiologists.
Although a good safety profile accounts for the spread of sedation, various complications might ensure. Furthermore of all the patients receiving sedation for diagnostic and therapeutic procedures, the pediatric population is the subgroup at the highest risk level and with the lowest tolerance of error.
In the last years the results of two large database studies have been published to lend some clarity on the rate and nature of adverse events involving sedation/anesthesia outside the operating room. Respiratory complications were the most frequently reported, and required critical anesthesiological competencies for a correct management to avoid poor outcomes.
Risk factors for adverse events during sedation/anesthesia have been evaluated by the 2016 SIAARTI(Società Italiana di Anestesia, Analgesia, Rianimazione e Terapia Intensiva)-SARNePI (Società di Anestesia e Rianimazione Neonatale e Pediatrica Italiana) guidelines for the standard of pediatric anesthesia, including patients' age, ASA (American Society of Anesthesiology) class, experience of the operators, and urgency/emergency conditions.
On the other hand, no suggestion is available either in current literature or guidelines, about a possible upper safety limit for the duration of sedation. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. To assess lung hypoventilation the LUSS-Lung Ultrasound Score will be used, since it is a validated and non invasive tool.
The study aims to assess the incidence of atelectasis and hypoventilated lung areas after sedation in children and evaluating possible risk factors for them. The investigators hypothesis that the length of sedation is correlated with the occurrence of lung atelectasis and hypoventilation.
This prospective observational cohort study study could suggest an upper safety limit for the duration of pediatric sedations, which is not reported in the available literature.
Consecutive children (age 1-8 yrs old) scheduled to undergo cerebral or medullary magnetic resonance imaging under deep sedation will be enrolled. In the investigators' center such MR imaging data acquisition (and the relevant sedation) ranges usually between 40 and 120 minutes. Enrollment will take place on the day of sedation.
Informed consent will be obtained from both parents at the preoperative visit or the day of the procedure.
The children will be sedated with propofol iv according to a standard clinical protocol and spontaneous breathing will be maintained throughout the study. The standard protocol has been internally validated both in the clinical and scientific setting.
Immediately after the induction of sedation, lung ultrasound will be performed and the imaging will be scored according to the lung ultrasound score(LUSS). Thereafter the child will be transferred into the magnetic resonance (MR) suite and the MR exam will be performed as required. After completion of MR imaging child will be transferred back to the recovery room and the sonographer will re- assess the LUSS before the discontinuation of sedation. Hence, two lung ultrasound evaluations will be performed: one at the beginning and one at the end of sedation.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children scheduled to undergo cerebral or medullary magnetic resonance imaging under deep sedation
Key inclusion criteria (3 listed)
- Children 1-8 years old (included)
- Informed consent of both parents
- Scheduled for elective cerebral or medullary Magnetic Resonance exam
Key exclusion criteria (4 listed)
- Any ongoing respiratory disease
- Contraindications to the use of propofol
- LUSS ≤12 at the first US assessment (a baseline maximum score 1 on all of the pulmonary fields)
- need for mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the Lung Ultrasound Score in children undergoing deep sedation
Time frame: through study completion, an average of 1 hour
Lung ultrasound score
2 secondary outcomes
Effect of sedation length on hypoventilation in children undergoing deep sedation
Time frame: through study completion, an average of 1 hour
Incidence of any respiratory and non-respiratory adverse event in children undergoing deep sedation
Time frame: through study completion, an average of 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- 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.
Marco Gemma, MD study chair
IRCCS San Raffaele, Milan, Italy
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 Sedative Adverse Reaction, run by IRCCS San Raffaele 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 3 inclusion and 4 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 13 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Gemma, MD (+39 0226437863, gemma.marco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Lung Ultrasound Score in children undergoing deep sedation (time frame: through study completion, an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.