Clinical trial NCT06448988: Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions (SPARK)
Official title: Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions in Patients Undergoing Elective Neurosurgery: a Cross-over Physiological Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventilation Therapy; Complications
Ventilator-Induced Lung Injury
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Variation in tidal volume distribution in the dependent and non-dependent lung during neurosurgical intervention, from supine to Park Bench position.
timeFrame: 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 outcomes:
measure: Airway closure incidence in the supine and Park Bench position
timeFrame: Airway closure incidence, during the procedure, in the supine and Park Bench position
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
affiliation: Fondazione Policlinico Gemelli, Rome
name: Giuliano Ferrone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grieco DL, Anzellotti GM, Russo A, Bongiovanni F, Costantini B, D'Indinosante M, Varone F, Cavallaro F, Tortorella L, Polidori L, Romano B, Gallotta V, Dell'Anna AM, Sollazzi L, Scambia G, Conti G, Antonelli M. Airway Closure during Surgical Pneumoperitoneum in Obese Patients. Anesthesiology. 2019 Jul;131(1):58-73. doi: 10.1097/ALN.0000000000002662.
citation: Mezidi M, Guerin C. Effects of patient positioning on respiratory mechanics in mechanically ventilated ICU patients. Ann Transl Med. 2018 Oct;6(19):384. doi: 10.21037/atm.2018.05.50.