NCT06658613

Brief Summary

Rigid bronchoscopy is commonly used for diagnosing and treating lung and airway diseases, including foreign body removal. Patients often experience atelectasis post-procedure, which lung ultrasound (LUS) can effectively detect. LUS is a rapid, noninvasive imaging technique that provides real-time evaluation without the need for patient transportation. In this observational study, researchers will assess the incidence and severity of atelectasis in patients undergoing elective rigid bronchoscopy, comparing those who were intubated and awakened post-procedure with those who were not intubated. The study aims to determine whether intubation influences the development of atelectasis after bronchoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 10, 2025

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 24, 2024

Last Update Submit

June 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Atelectasis

    Lung ultrasound score (LUS) will be used for the detection of atelectasis. Each lung will be evaluated separately and scores will be recorded. Scores will be obtained from 6 regions for each lung (anterior superior/inferior, middle superior/inferior, posterior superior/inferior) for a total of 12 regions for each patient. Scoring will be based on the 'B lines' pattern seen on LUS (B0, B1, B2, B3, indicating progressive atelectasis). A score of 0 to 3 points will be given for each lung field measured, for a total LUS of 0-36.

    From the preinduction period in the operating theater to the postoperative recovery of the patient again in the operating theater.

Study Arms (2)

Group C

Patients not intubated at the end of the bronchoscopy during the neuromuscular block reversal and weaning course.

Group I

Patients intubated at the end of the bronchoscopy during the neuromuscular block reversal and weaning course.

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

1-17 year old pediatric patients who will undergo elective rigid bronchoscopy under general anesthesia by the pediatric surgery department at Marmara University Training and Research Hospital.

You may qualify if:

  • Elective rigid bronchoscopy
  • American Society of Anaesthesiologists (ASA) physical status I or II

You may not qualify if:

  • Emergent rigid bronchoscopy
  • ASA III or above
  • Patients left intubated after the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Ruslan Abdullayev

    Marmara University Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

October 25, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 10, 2025

Record last verified: 2024-10

Locations