Effect of Sedation on Pulmonary Aeration in Children

NCT03392012 | Unknown

• 1 other identifier: 140/INT/2017
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Sedative Adverse Reaction

Keywords

anesthesia, patient safety, respiratory complications

Outcome Measures

Primary Outcomes (1)

• Changes in the Lung Ultrasound Score in children undergoing deep sedation

  Lung ultrasound score

  through study completion, an average of 1 hour

Secondary Outcomes (2)

• Effect of sedation length on hypoventilation in children undergoing deep sedation

  through study completion, an average of 1 hour

• Incidence of any respiratory and non-respiratory adverse event in children undergoing deep sedation

  through study completion, an average of 1 hour

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children scheduled to undergo cerebral or medullary magnetic resonance imaging under deep sedation

You may qualify if:

• Children 1-8 years old (included)
• Informed consent of both parents
• Scheduled for elective cerebral or medullary Magnetic Resonance exam

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

S. Raffaele Hospital

Milan, MI, 20132, Italy

RECRUITING

Study Officials

• Marco Gemma, MD

  IRCCS San Raffaele, Milan, Italy

  STUDY CHAIR

Central Study Contacts

Marco Gemma, MD

CONTACT

+39 0226437863; gemma.marco@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 5, 2018
• Study Start: February 6, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)