Health TrialsbyHealthPanel

Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation

ConditionThe Direction of Blocker Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University, China

About this trial

This trial is a practical, multicenter, prospective, parallel grouping, randomized controlled,two-arm study. This study will be conducted in three centers including the First Hospital of China Medical University, Seoul National University Hospital and the University Clinical Center of Serbia. The investigators aim to investigate the effect of different occlusion angles of disposable tracheal blocker on right one-lung ventilation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ranged from 18 to 65 years old;

American Society of Anesthesiologists (ASA) grade I-III;

No history of drug allergy or abnormal anesthesia;

Patients undergoing right thoracoscopic surgery;

Disqualifiers

Patients with a history of acute lung injury or ARDS within 3 months;

Cardiac function class IV (New York Heart Association classification);

Chronic renal failure (renal cell filtration rate <30ml min-11.73m-2), severe liver disease;

Patients with blurred consciousness and cognitive dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • the tip opening angle to the left

    Device

    After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope.

  • the tip opening angle to the right

    Device

    After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: the tip opening angle to the leftExperimental treatment 1 intervention
Group B: the tip opening angle to the rightPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Satisfaction with the collapse of the right lung

The pirimary outcome is the comparison the effects of different occluder opening directions on lung collapse by one surgeon using lung collapse score (1-4, 4 means the best)

Time frame
On the 3 minutes after one lung ventilation

Secondary outcomes

1

The first time success rate of blocker implantation

The first time success rate of blocker implantation

Time frame
On the time of blocker implantation 30 seconds

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University, China

Lead sponsor

Source ClinicalTrials.gov
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