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

Ventilator-Induced Lung Injury Clinical Trial

— SPARK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448988
• Other study ID #: FPG ID 6738
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Giuliano Ferrone, MD
• Phone: +390630151
• Email: giulianoferrone[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: July 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Injury
• Ventilation Therapy; Complications
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation 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	Airway closure incidence 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