Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Brief Title:
Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions SPARK
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions in Patients Undergoing Elective Neurosurgery a Cross-over Physiological Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARK
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None