NCT04194177

Brief Summary

the evaluation of distribution of mechanical ventilation during robotic surgery

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 Jan 2017

Typical duration for not_applicable

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

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 8, 2019

Last Update Submit

December 8, 2019

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

  • distribution of tidal volume

    at the end of surgery

Secondary Outcomes (1)

  • driving pressure

    at the end of surgery

Study Arms (2)

protective

EXPERIMENTAL
Other: mechanical ventilation during robotic surgery

conventional

ACTIVE COMPARATOR
Other: mechanical ventilation during robotic surgery

Interventions

mechanical ventilation during robotic surgeryOTHER

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

conventionalprotective

Eligibility Criteria

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

You may qualify if:

  • age\>18
  • informed consent
  • robotic surgery

You may not qualify if:

  • age\<18
  • no consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II department of Anesthesia and Critical Care

Naples, 80100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36797394DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

maria vargas, MD

CONTACT

+393396876440vargas.maria82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resercher

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 11, 2019

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

February 1, 2020

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

IT(1)