Cardiac Output Clinical Trial
Official title:
Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study
NCT number | NCT03111797 |
Other study ID # | darnord2017-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | May 30, 2017 |
Verified date | April 2020 |
Source | Hospital Nord |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This prospective and observational cohort studies the morphine consumption difference during
the first 48 hours after a lung lobectomy between patients operated with a robot assisted or
a video-assisted technique for a lung cancer lobectomy.
Second outcome was to search eventual cardiac output difference during the surgery in 100
patients (50 in each group) using a non invasive monitoring device of cardiac output
All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were
included.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 30, 2017 |
Est. primary completion date | April 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Volunteers - Mono lobectomy of lung for early stage cancer (T2Nx and earlier) - Video or robot assisted procedure Exclusion Criteria: - Advanced stage of cancer (T3Nx and greater) - Need of thoracotomy conversion during procedure - Morphine intolerance or addiction. |
Country | Name | City | State |
---|---|---|---|
France | Departement anesthesie reanimation hopital nord | Marseille |
Lead Sponsor | Collaborator |
---|---|
Hospital Nord | Gary DUCLOS (Medical Doctor, investigator) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine consumption | morphine consumption for each patient using a self patient - controled morphine pump | 48 hours after surgery | |
Secondary | cardiac output | continuous cardiac output during surgery procedure | during 30 minutes after incision and optic introduction |
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