Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT02857504
Status:
UNKNOWN
Last Update Posted:
2017-04-17
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Lung Ventilation: Double Lumen Tube
Sponsor:
University Medical Centre Ljubljana
Organization:
Study Overview
Official Title:
One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS).
OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.
OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.
Detailed Description:
One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS)(1).
OLV can be provided by double lumen tube (DLT) or bronchial blocker. There are advantages and disadvantages of both techniques, but DLT is more recommended because it allows total emptying of the operated lung. Air and secretion can be aspirated through the wide lumen of the tube during the surgery (2, 3).
There are many kinds of DLT which differ according to shape and material. Most commonly used are left sided DLT which are placed into left main bronchus and right or left lungs can be closed or emptied. Left sided tube have a hook which is placed on the carina to prevent displacement of the tube. There are also DLT without the hook which are more gentle and easier to place in the left main bronchus (4,5). After the insertion of the left tube without the hook, bronchoscopy is recommended to check the position of the tube (6,7,8,9).
Some severe complications (injury of the bronchial tree) after insertion of the hooked tube are found in the literature (10). The investigators have published such complication from our experience (11).
Each anesthesiologist decides individually which kind of DLT to use as there are no studies which have objectivised the advantage of either technique. There is only one study where they have compared both techniques but they have found no difference. That is why the investigators decided to study which technique is better so this can be included in our standard operative procedure.
OLV can be provided by double lumen tube (DLT) or bronchial blocker. There are advantages and disadvantages of both techniques, but DLT is more recommended because it allows total emptying of the operated lung. Air and secretion can be aspirated through the wide lumen of the tube during the surgery (2, 3).
There are many kinds of DLT which differ according to shape and material. Most commonly used are left sided DLT which are placed into left main bronchus and right or left lungs can be closed or emptied. Left sided tube have a hook which is placed on the carina to prevent displacement of the tube. There are also DLT without the hook which are more gentle and easier to place in the left main bronchus (4,5). After the insertion of the left tube without the hook, bronchoscopy is recommended to check the position of the tube (6,7,8,9).
Some severe complications (injury of the bronchial tree) after insertion of the hooked tube are found in the literature (10). The investigators have published such complication from our experience (11).
Each anesthesiologist decides individually which kind of DLT to use as there are no studies which have objectivised the advantage of either technique. There is only one study where they have compared both techniques but they have found no difference. That is why the investigators decided to study which technique is better so this can be included in our standard operative procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: