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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Marco Gemma, MD contact

+39 0226437863

gemma.marco@hsr.it

Italy1 site, 1 recruiting
  • S. Raffaele Hospital

    Milan, MI, 20132

    Marco Gemma, MD, ++390226432656, gemma.marco@hsr.it

    Recruiting

Other trials in Italy

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.

Keywords
anesthesia, patient safety, respiratory complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Effect of sedation length on hypoventilation in children undergoing deep sedation

    Sedation length (min)

    Measured: through study completion, an average of 1 hour

  2. 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.

  1. First posted5 Jan 2018
  2. Study start6 Feb 2018
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion30 Dec 2018 (estimated)

Resources

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)
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

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.

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