Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions (SPARK) (SPARK)

October 21, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions in Patients Undergoing Elective Neurosurgery: a Cross-over Physiological Study

The primary objective of this prospective observational physiological study is to evaluate the variation in regional distribution of intrapulmonary volume in the dependent and non-dependent lung regions in patients undergoing neurosurgical intervention between supine and Park-Bench position.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Park-Bench position is a variant of the lateral position used in neurosurgical interventions where lesions of the posterior cranial fossa and ponto-cerebellar angle need to be approached. The patient is placed in a lateral-oblique position with the arm on the side they are lying on extending out of the operating bed and supported by an external support. The head is fixed in flexion and rotation with the Mayfield headrest immobilizing the head, allowing exposure of the surgical region of interest.

In the lateral decubitus position, several factors contribute to changing respiratory mechanics: airway resistance increases and compliance decreases.

Furthermore, the gravitational gradient is altered, which is one of the main factors in the regional distribution of intrapulmonary air volume and tidal volume distribution: the phenomenon of overdistension of the non-dependent lung and collapse of the dependent lung could occur.

Fully understanding these physiological changes could optimize mechanical ventilation settings and thus avoid causing damage to lung parenchyma (Ventilator-Induced Lung Injury).

The primary hypothesis of this physiological study is to evaluate changes in regional distribution of intrapulmonary volume when transitioning from the supine position to the Park-Bench position.

Study Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The investigators will enroll all patients scheduled for elective neurosurgery in Park-Bench position in Fondazione Policlinico Universitario "Agostino Gemelli", Rome, Italy

Description

Inclusion Criteria:

  • Age >18
  • Patients scheduled for elective neurosurgery in Park-Bench position.

Exclusion Criteria:

  • Age < 18
  • BMI > 30 kg/m2
  • Obstructive or restrictive lung disease with oxygen supplementation
  • Pacemaker
  • Pregnancy
  • Absence of history of pulmonary embolism, thoracic surgery or chest wall abnormalities, organ transplant, lung metastases
  • New York Heart Association >2 or hemodynamic instability (Mean Arterial Pressure<60mHg)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supine position
To evaluate, during the procedure, the variation in regional distribution of intrapulmonary volume in the dependent and non-dependent lung regions in patients undergoing neurosurgical intervention between supine and Park-Bench position.
Other: Park Bench position
To evaluate, during the procedure, the variation in regional distribution of intrapulmonary volume in the dependent and non-dependent lung regions in patients undergoing neurosurgical intervention between supine and Park-Bench position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in tidal volume distribution in the dependent and non-dependent lung during neurosurgical intervention, from supine to Park Bench position.
Time Frame: Variation, during the procedure, in tidal volume distribution in the dependent and non-dependent lung during neurosurgical intervention, from supine to Park Bench position.
Variation in tidal volume distribution in the dependent and non-dependent lung during neurosurgical intervention, from supine to Park Bench position.
Variation, during the procedure, in tidal volume distribution in the dependent and non-dependent lung during neurosurgical intervention, from supine to Park Bench position.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway closure incidence in the supine and Park Bench position
Time Frame: Airway closure incidence, during the procedure, in the supine and Park Bench position
Airway closure incidence in the supine and Park Bench position
Airway closure incidence, during the procedure, in the supine and Park Bench position

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Giuliano Ferrone, MD, Fondazione Policlinico Gemelli, Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPG ID 6738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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