NCT02959515

Brief Summary

The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and OLV+capnothorax and CPAP.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 9, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

October 26, 2016

Last Update Submit

November 8, 2016

Conditions

One-Lung VentilationThoracic Surgery Video AssistedSupine Position

Outcome Measures

Primary Outcomes (1)

  • Oxygen delivery

    Oxygen delivery is cardiac output times arterial oxygen content

    10 min after institution of capnothotax or capnothorax and CPAP

Secondary Outcomes (1)

  • Pulmonary shunt

    10 min after institution of capnothotax or capnothorax and CPAP

Study Arms (2)

Capnothorax

ACTIVE COMPARATOR

Capnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg .Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded.

Procedure: Capnothorax

Capnothorax and CPAP

ACTIVE COMPARATOR

Capnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1. Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded.

Procedure: Capnothorax and CPAP

Interventions

CapnothoraxPROCEDURE

Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity.

Capnothorax
Capnothorax and CPAPPROCEDURE

Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity. Continuous positive airway pressure of 10 cmH2O delivered by CF 800 Continuous flow CPAP, Drager.

Capnothorax and CPAP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pts electively subjected to OLV in supine position for VATS ablation of AF and requiring OLV for \> 30'

You may not qualify if:

  • Expected difficult positioning of DLT, severe obesity BMI \> 35, uncompensated cardiac disease. OLV \< 30'.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

MeSH Terms

Conditions

Deception

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

luca salvi, MD

CONTACT

+39 02 58002LUCA.SALVI@CCFM.IT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia & ICU Senior consultant

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 9, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

November 9, 2016

Record last verified: 2016-10

Locations

IT(1)