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Enrolling by invitation NCT06448988

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

Observational Ventilation Therapy; Complications Ventilator-Induced Lung Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Park Bench position.
Who it may be relevant to
Registry conditions: Ventilation Therapy; Complications, Ventilator-Induced Lung Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Italy · 1 center
  • Fondazione Policlinico Gemelli — Rome

Publications

  • 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. PMID 30882475
  • 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. PMID 30460258

Identifiers

NCT: NCT06448988 · FPG ID 6738

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗