Ventilation Therapy; ComplicationsSPARKNCT06448988
Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions (SPARK)
An observational study of Ventilation Therapy; Complications and Ventilator-Induced Lung Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation Therapy; Complications, Ventilator-Induced Lung Injury
- What is being tested?
- Park Bench position
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will enroll all patients scheduled for elective neurosurgery in Park-Bench position in Fondazione Policlinico Universitario "Agostino Gemelli", Rome, Italy
Who may be able to join
- Age >18
- Patients scheduled for elective neurosurgery in Park-Bench position.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions in Patients Undergoing Elective Neurosurgery: a Cross-over Physiological Study
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.
Read the 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.
- Being tested
- Park Bench position
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Park Bench positionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Park Bench position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 in the supine and Park Bench position
Measured: Airway closure incidence, during the procedure, in the supine and Park Bench position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start6 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuliano Ferrone, MD, Principal investigator, Fondazione Policlinico Gemelli, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448988
- Sponsor's protocol ID
- FPG ID 6738
- Acronym
- SPARK
- Status last verified
- Oct 2024
- First submitted
- 28 May 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30882475Mezidi 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.
PubMed 30460258
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions in Patients Undergoing Elective Neurosurgery: a Cross-over Physiological Study
- ClinicalTrials.gov ID
- NCT06448988
- Acronym / sponsor ID
- SPARK / FPG ID 6738
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supine position | – | Other: Park Bench positionTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will enroll all patients scheduled for elective neurosurgery in Park-Bench position in Fondazione Policlinico Universitario "Agostino Gemelli", Rome, Italy
Key inclusion criteria (2 listed)
- Age >18
- Patients scheduled for elective neurosurgery in Park-Bench position.
Key exclusion criteria (7 listed)
- Age < 18
- BMI > 30 kg/m2
- Obstructive or restrictive lung disease with oxygen supplementation
- Pacemaker
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Park Bench positionTo 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 | Supine position |
Primary outcome
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.
Variation in tidal volume distribution in the dependent and non-dependent lung during neurosurgical intervention, from supine to Park Bench position.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 30882475Grieco 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.
- Results publication: PubMed 30460258Mezidi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuliano Ferrone, MD principal investigator
Fondazione Policlinico Gemelli, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation Therapy; Complications and Ventilator-Induced Lung Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.