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

NCT06448988 | Enrolling By Invitation

• 1 other identifier: FPG ID 6738
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation Therapy; Complications; Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Airway closure incidence in the supine and Park Bench position

  Airway closure incidence, during the procedure, in the supine and Park Bench position

Study Arms (1)

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

Interventions

Park Bench position OTHER

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.

Supine position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00168, Italy

Location

Related 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.

  PMID: 30882475 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Giuliano Ferrone, MD

  Fondazione Policlinico Gemelli, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: June 6, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)