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Clinical Trials/NCT02857504
NCT02857504UnknownNot Applicable

One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook

University Medical Centre Ljubljana1 site in 1 country30 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
intubation

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • planned thoracotomy or VATS surgical technique
  • with ASA (American Society of Anesthesiologist) physical status 1-3.

Exclusion Criteria

  • severe heart illness (NYHA >3),
  • severe pulmonary obstructive disease (FEV1<40%),
  • neurologic disorders and
  • patients with other respiratory or lung disease.

Arms & Interventions

double lumen tube with a hook

Other

The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped.

Intervention: double lumen tube with a hook (Device)

double lumen tube without a hook

Other

Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left.

Intervention: double lumen tube without a hook (Device)

Outcomes

Primary Outcomes

intubation

Time Frame: intraoperative

The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lea Andjelkovic

MD

University Medical Centre Ljubljana

Study Sites (1)

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