NCT03505242

Brief Summary

Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

August 30, 2017

Last Update Submit

April 12, 2018

Conditions

Minimally Invasive Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • oxygenation

    record SpO2 and PaO2 during selective ventilation

    intraoperative

Secondary Outcomes (1)

  • degree of pulmonary collapse

    intraoperative

Study Arms (2)

BB

EXPERIMENTAL
Device: bronchial blocker for BB group

DLT

EXPERIMENTAL
Device: double lumen tube for DLT group

Interventions

bronchial blocker for BB groupDEVICE

Using bronchial blocker to block right middle lower lobe during surgery.

BB
double lumen tube for DLT groupDEVICE

Using double lumen tube to achieve single lung ventilation during surgery.

DLT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA II-III
  • BMI 18-31
  • elective minimally invasive cardiac surgery by right thoracotomy

You may not qualify if:

  • asthma
  • COPD
  • previous lung surgery
  • previous cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Kefang Guo

CONTACT

+8613817706936guo.kefang@zs-hospital.sh.cn

Lin Jin

CONTACT

+8613917131195jin.lin@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

April 23, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share