NCT06358027

Brief Summary

In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

April 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

16 days

First QC Date

April 5, 2024

Last Update Submit

April 5, 2024

Conditions

Keywords

Lung UltrasonographyAtelectasisPostoperative Pulmonary ComplicationsPressure Support Ventilation

Outcome Measures

Primary Outcomes (1)

  • Modified Transthoracic Ultrasound Score

    Both lungs were determined as anterior and posterior axillary lines as anatomical markers and divided into a total of 12 regions, 4 in the anterior thoracic wall, 4 in the lateral wall, and 4 in the posterior region. While the anterior and lateral regions were examined in the supine position by placing the probe perpendicular to the thoracic wall and longitudinal in the intercostal spaces with the bat sign displayed, especially the posterior regions close to the diaphragm were examined by placing the probe transversely in the intercostal spaces by turning the patient opposite. According to the systematic LUS protocol, each patient was evaluated for approximately 10-15 minutes and optimum images were obtained.Each area was scored on a scale of 0-3 according to the degree of atelectasis, and a total score between 0 (normal lung ventilation image) and 36 (total loss of ventilation) was calculated.

    two weeks

Study Arms (2)

pressure support ventilation group

when the patients were ready for extubation, anesthesia was terminated by one of the selected pressure support ventilation

Diagnostic Test: lung ultrasound

manual ventilation group

when the patients were ready for extubation, anesthesia was terminated by one of the selected manual ventilation wake-up methods at the initiative of the relevant anesthesiologist.

Diagnostic Test: lung ultrasound

Interventions

lung ultrasoundDIAGNOSTIC_TEST

The patients included in the study underwent lung imaging with lung ultrasound score twice, in the preoperative preparation room and in the postoperative recovery unit.Both lungs were determined as anterior and posterior axillary lines as anatomical markers and divided into a total of 12 regions, 4 in the anterior thoracic wall, 4 in the lateral wall, and 4 in the posterior region. In our study, we will use the modified LUS scoring, which has been shown to be more sensitive in the diagnosis of postoperative atelectasis in the recovery unit, based on existing literature reviews. The degree of the atelectasis will be determined according to do modified lung ultrasound score. Lung ultrasound score imaging of all patients was performed by the same anesthesiologist.

Also known as: Modified Transthoracic Ultrasound Scoring System
manual ventilation grouppressure support ventilation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients 18 years of age or older and American Society of Anesthesiologists (ASA) physical status I and III who were scheduled for general anesthesia were included in this prospective observational study.

You may qualify if:

  • Patients undergoing general anesthesia with supine position
  • Endotracheal intubations and mechanical ventilation during general anesthesia
  • Operation time is more than 2 hours

You may not qualify if:

  • Patients who will undergo surgical intervention under emergency conditions
  • Pregnancy
  • Upper respiratory tract disease in the last 3 weeks
  • Previous lung surgery
  • Advanced cardiac and/or pleural lung disease and chest wall deformity, and primary or metastatic lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

April 5, 2024

Primary Completion

April 21, 2024

Study Completion

April 30, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share