A Unique Device for Independent Lung Ventilation

NCT02786862 | Completed

• 1 other identifier: MULublin
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of anaesthetic and intensive care management. At present, the sole method of improving gas exchange restricted by ventilation/perfusion mismatching is independent ventilation with two ventilators. Recently, however, a unique device has been developed, enabling ventilation of independent lungs in 1:1, 2:1, 3:1, and 5:1 proportions. The main goal of the study was to evaluate the device's utility, precision and impact on biomechanical lung parameters during thoracic surgery under general anaesthesia with double lumen tube intubation. Secondly- to measure the gas distribution in supine and lateral decubitus position.

Conditions

Anesthesia

Keywords

mechanical ventilation; independent ventilation; ventilation/perfusion mismatch; thoracic anesthesia

Outcome Measures

Primary Outcomes (1)

• Tidal volume distribution during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.

  tidal volume

  up to 12 months

Secondary Outcomes (2)

• Peak respiratory pressure measuring during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.

  up to 12 months

• Dynamic compliance measuring during conventional and independent in 1:1 proportion ventilation in supine, left and right decubitus positions.

  up to 12 months

Other Outcomes (3)

• Impact of supine to left and supine to right decubitus position changes on tidal volume distribution during conventional and independent in 1:1 proportion ventilation.

  up to 12 months

• Impact of supine to left and supine to right decubitus position changes on peak respiratory pressure, during conventional and independent in 1:1 proportion ventilation.

  up to 12 months

• Impact of supine to left and supine to right decubitus position changes on dynamic compliance during conventional and independent in 1:1 proportion ventilation.

  up to 12 months

Study Arms (1)

Ventilation

EXPERIMENTAL

Measurements were made for conventional and independent at 1:1 proportion ventilation in supine position; then independent ventilation was discontinued and patient was moved to right or left decubitus position due to left or right lung surgery. Then were made measurements for conventional anaesthetic practices and followed independent at 1:1, 2:1, 3:1, 5:1 proportions ventilation routines. Constantly were monitored expired volume, peak respiratory pressure, dynamic compliance separately for each lung. Measurements covered also hemodynamic (MAP, HR) and oxygenation (SpO2). These attributes were documented at each point of the study. Subsequently, the control system was disconnected and performed typical anaesthetic procedures for thoracic surgery with a one-lung ventilation procedure.

Other: independent ventilation

Interventions

independent ventilation OTHER

comparison conventional and independent 1:1 ventilation

Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I and II patients who underwent elective thoracic surgery under general anaesthesia, with double lumen tube intubation and one lung ventilation during surgical procedure.

You may not qualify if:

• All patients with asthma or chronic obstructive pulmonary disease, history of thoracotomy, assessed as ASA III, with difficult airway conditions, kyphoscoliosis or other alterations of chest wall or severe obesity were excluded

Sponsors & Collaborators

• Medical University of Lublin: lead

Related Publications (2)

• Darowski M, Englisz M. Artificial ventilation of the lungs for emergencies. Front Med Biol Eng. 2000;10(3):177-83. doi: 10.1163/15685570052062576.

  PMID: 11014679 BACKGROUND

• Sawulski S, Nestorowicz A, Sawicki M, Kowalczyk M, Ston M. [Independent lung ventilation during general anaesthesia--preliminary report]. Anestezjol Intens Ter. 2010 Jan-Mar;42(1):6-10. Polish.

  PMID: 20608207 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Slawomir Sawulski, M.D., Ph.D.

  Medical University of Lublin, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: June 1, 2016
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Row data will be attached as supplementary files during publication process
• Access Criteria: Data will be available for everybody