EIT_ROBO: Evaluation of Thoracic Impedance Tomography During Robotic Surgery

• Sponsor: Federico II University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04194177
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

the evaluation of distribution of mechanical ventilation during robotic surgery

Condition or Disease	Intervention/Treatment	Phase
Atelectasis	Other: mechanical ventilation during robotic surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Two Types of Mechanical Ventilation During Robotic Surgery With the Thoracic Impedance Tomography
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: protective	Other: mechanical ventilation during robotic surgery; protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg
Active Comparator: conventional	Other: mechanical ventilation during robotic surgery; protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg

Outcome Measures

Primary Outcome Measures

1. distribution of tidal volume [at the end of surgery]

Secondary Outcome Measures

1. driving pressure [at the end of surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age>18

• informed consent

• robotic surgery

Exclusion Criteria:

• age<18

• no consent for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples Federico II department of Anesthesia and Critical Care	Naples		Italy	80100

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Vargas, resercher, Federico II University
• ClinicalTrials.gov Identifier: NCT04194177
• Other Study ID Numbers: EIT_OR
• First Posted: Dec 11, 2019
• Last Update Posted: Dec 11, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Atelectasis

Study Results

No Results Posted as of Dec 11, 2019