NCT06383156

Brief Summary

The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 14, 2024

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

December 23, 2023

Last Update Submit

May 12, 2024

Conditions

Keywords

UltrasoundClinical auscultationFluoroscopy

Outcome Measures

Primary Outcomes (1)

  • the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope

    The findings collected by the three methods will be checked for its specificity by endobronchial bronchoscopy

    2 months after data collection

Secondary Outcomes (1)

  • sensitivity and accuracy in confirming the position of the LDLT.

    2 months after data collection

Study Arms (3)

Auscultation

ACTIVE COMPARATOR

correct position of LDLT during single lung ventilation will be confirmed by clinical methods.

Device: Double lumen endotracheal tube

Ultrasound

ACTIVE COMPARATOR

correct position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation

Device: Double lumen endotracheal tube

Fluoroscopy

ACTIVE COMPARATOR

correct position of LDLT during single lung ventilation will be confirmed when fluoroscopy visualizes the left bronchial cuff and lumen in left main bronchus.

Device: Double lumen endotracheal tube

Interventions

correct position of LDLT during single lung ventilation

AuscultationFluoroscopyUltrasound

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60
  • Physical status: ASA 1-3 that were scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed Consent.

You may not qualify if:

  • Anticipated difficult intubation.
  • Tracheostomy tube.
  • Concurrent pneumothorax.
  • Pleural effusion and emphysema.
  • History of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity \< 50% of the predicted values).
  • Body mass index more than 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • ahmed Morsy, master

    Anesthesia assistant lecturer ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fathy Tash, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2023

First Posted

April 25, 2024

Study Start

June 15, 2024

Primary Completion

December 18, 2024

Study Completion

February 1, 2025

Last Updated

May 14, 2024

Record last verified: 2023-12