NCT03563612

Brief Summary

In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

May 26, 2018

Last Update Submit

June 9, 2018

Conditions

One Lung VentilationContinuous Positive Airway PressureDifferential Lung Ventilation

Keywords

one lung ventilationcontinuous positive airway pressuredifferential lung ventilation

Outcome Measures

Primary Outcomes (1)

  • arterial blood oxygenation

    PaO2

    intraoperative

Secondary Outcomes (2)

  • interference with surgical field exposure

    intraoperative

  • airway pressure in the dependent lung during one lung ventilation

    intraoperative

Study Arms (2)

cpap first, differential ventilation later

ACTIVE COMPARATOR
Device: cpap

differential ventilation first, cpap late

ACTIVE COMPARATOR
Device: cpap

Interventions

cpapDEVICE

application of cpap to the non-dependent lung, during one lung ventilation

cpap first, differential ventilation laterdifferential ventilation first, cpap late

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients diagnised with lung cancer
  • Scheduled to have thoracoscopic lung lobectomy -

You may not qualify if:

  • Pregnancy
  • ASA\>=4
  • Difficult intubation -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Related Publications (1)

  • Kremer R, Aboud W, Haberfeld O, Armali M, Barak M. Differential lung ventilation for increased oxygenation during one lung ventilation for video assisted lung surgery. J Cardiothorac Surg. 2019 May 6;14(1):89. doi: 10.1186/s13019-019-0910-2.

    PMID: 31060627DERIVED

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: prospective randomized controlled crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Anesthesiologist

Study Record Dates

First Submitted

May 26, 2018

First Posted

June 20, 2018

Study Start

April 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

IL(1)