Evaluation of Thoracic Impedance Tomography During Robotic Surgery

NCT ID: NCT04194177

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-02-29

Brief Summary

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the evaluation of distribution of mechanical ventilation during robotic surgery

Detailed Description

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Conditions

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Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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protective

Group Type EXPERIMENTAL

mechanical ventilation during robotic surgery

Intervention Type OTHER

protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg

conventional

Group Type ACTIVE_COMPARATOR

mechanical ventilation during robotic surgery

Intervention Type OTHER

protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg

Interventions

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mechanical ventilation during robotic surgery

protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age\>18
* informed consent
* robotic surgery

Exclusion Criteria

* age\<18
* no consent for the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Maria Vargas

resercher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II department of Anesthesia and Critical Care

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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maria vargas, MD

Role: CONTACT

Phone: +393396876440

Email: [email protected]

Facility Contacts

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Maria Vargas, MD

Role: primary

References

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Buonanno P, Marra A, Iacovazzo C, Merola R, De Siena AU, Servillo G, Vargas M. Electric impedance tomography and protective mechanical ventilation in elective robotic-assisted laparoscopy surgery with steep Trendelenburg position: a randomized controlled study. Sci Rep. 2023 Feb 16;13(1):2753. doi: 10.1038/s41598-023-29860-x.

Reference Type DERIVED
PMID: 36797394 (View on PubMed)

Other Identifiers

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EIT_OR

Identifier Type: -

Identifier Source: org_study_id