Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation

• Sponsor: Biruni University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05791045
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief Summary

In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Time	Procedure: single vs double	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• Official Title: Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation Study in Endoscopic Thoracic Sympathetic Blockade
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: double lumen tube In the DLT group, the lung on the side to be treated was distinguished from the ventilator and extinguished and single lung ventilation was performed with the other lung.	Procedure: single vs double; we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade
Active Comparator: single lumen tube In the SLT group, after thoracoscopic input, the anesthetist was in contact with the surgeon and his lung pressures were reduced manually until the lowest pressure, where the surgeon's vision was optimal.	Procedure: single vs double; we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade

Outcome Measures

Primary Outcome Measures

1. anesthesia time [1 year]

   anesthesia time during intubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 135 patients underwent bilateral ETSB procedure under general anesthesia

Exclusion Criteria:

• patients who underwent one sided ETSB

• patients under the age of 18

• Patients over 65 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ilke Kupeli	Istanbul		Turkey	34250

Sponsors and Collaborators

• Biruni University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hashmonai M, Kopelman D. History of sympathetic surgery. Clin Auton Res. 2003 Dec;13 Suppl 1:I6-9. doi: 10.1007/s10286-003-1103-5.

• Responsible Party: ILKE KUPELI, Assoc. prof, Biruni University
• ClinicalTrials.gov Identifier: NCT05791045
• Other Study ID Numbers: Biruni HLM
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 30, 2023