Effect of Recruitment Maneuver on Intracranial PressureNCT04935008
Evaluation of Intracranial Pressure During Mechanical Ventilation Recruitment Maneuver
A study testing The recruitment maneuver in people with Effect of Recruitment Maneuver on Intracranial Pressure, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Recruitment maneuver is used to reopen atelectasis alveoli. Positive airway pressure applied during the recruitment maneuver may increase intrathoracic pressure, resulting in hemodynamic instability, venous return disorders, and increased intracranial pressure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Effect of Recruitment Maneuver on Intracranial Pressure
- What is being tested?
- The recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 16 Feb 2022
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Patients followed in the Intensive Care Unit (ICU)
- Patients on mechanical ventilation support
- Patients diagnosed with ARDS according to the Berlin criteria
- Patients with oxygen saturation (SpO2) ≤ 92%
Who cannot join
- Younger than 18
- Patients with increased inotropic drug requirement or mean arterial pressure <65 mmHg in the last 2 hours
- Patients with intracranial hypertension
- Patients with acute coronary syndrome
- Patients with hypercapnia, pneumothorax, subcutaneous emphysema, and pneumomediastinum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Lung Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: A Prospective Experimental Study
Recruitment maneuver is used to reopen atelectasis alveoli. Positive airway pressure applied during the recruitment maneuver may increase intrathoracic pressure, resulting in hemodynamic instability, venous return disorders, and increased intracranial pressure. Our study will examine the effect of recruitment maneuver on intracranial pressure by evaluating Optic Nerve Sheath Diameter change.
Read the detailed description
The therapeutic goal of mechanical ventilation shifts from maintaining regular gas exchange to preventing ventilator-induced lung injury. Atelectasis aggravates lung injury by reducing the lung size available for tidal ventilation. By preventing atelectasis with Positive End Expiratory Pressure (PEEP) and recruitment maneuvers, the end-expiratory lung volume can be increased, and lung damage can be reduced.
Although the recruitment maneuver improves oxygenation and reduces mortality, especially in patients with Acute Respiratory Distress Syndrome (ARDS), adverse side effects are sometimes observed. Most important of these are the risk of barotrauma after positive airway pressure applications, increased intrathoracic pressure and hemodynamic instability, and increased intracranial pressure risk after venous return disorder.
Our study aimed to evaluate the effect of recruitment maneuver on intracranial pressure by measuring optic nerve diameter with ultrasound before and after its application in patients with ARDS with impaired oxygenation and followed up with mechanical ventilator support.
- Being tested
- The recruitment maneuver
- Keywords
- Recruitment maneuver, Intracranial pressure, Optic Nerve Sheath Diameter, Acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The recruitment maneuverDiagnostic test
Also called Measurement of optic nerve sheath diameter with the help of ultrasonography
In patients with ARDS, 30 cm H2O positive pressure support and 30 seconds recruitment maneuver will be applied. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver. Optic nerve diameter will be evaluated with a linear probe on the eyeball before and after the collection maneuver, taking a value of 3 mm from the eyeball.
| Study group | Role | What they receive |
|---|---|---|
| Effect of recruitment maneuver on intracranial pressure | Experimental | A recruitment maneuver will be performed in patients with decreased oxygen saturation due to atelectasis by applying 30 cm H2O positive pressure support for 30 seconds. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver. Receives: Diagnostic Test: The recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)
Change in optic nerve sheath diameter (ONSD) after the recruitment maneuver in acute respiratory distress syndrome (ARDS) patients
Measured: 1 minute
Secondary outcomes (3)
Effect of recruitment maneuver on respiratory compliance (Cdyn)
Change in respiratory compliance (Cdyn) after the recruitment maneuver
Measured: 10 minute
Effect of recruitment maneuver on oxygen saturation (SpO2)
Change in oxygen saturation (SpO2) after the recruitment maneuver
Measured: 10 minute
The effect of change of respiratory compliance (Cdyn) on optic nerve sheath diameter (ONSD) after the recruitment maneuver
Effect of respiratory compliance (Cdyn) change on optic nerve sheath diameter (ONSD) change after recruitment maneuver
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Jan 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Effect of Recruitment Maneuver on Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all patients in mechanical ventilation
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Komurcu, Ondokuz Mayıs University
- Investigators
- özgür kömürcü, 1, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935008
- Sponsor's protocol ID
- 2020/528
- Status last verified
- Mar 2022
- First submitted
- 10 Jun 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortes I, Penuelas O, Esteban A. Acute respiratory distress syndrome: evaluation and management. Minerva Anestesiol. 2012 Mar;78(3):343-57.
PubMed 22357372Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. Am J Respir Crit Care Med. 1998 Jan;157(1):294-323. doi: 10.1164/ajrccm.157.1.9604014. No abstract available.
PubMed 9445314Gattinoni L, Agostoni A, Pesenti A, Pelizzola A, Rossi GP, Langer M, Vesconi S, Uziel L, Fox U, Longoni F, Kolobow T, Damia G. Treatment of acute respiratory failure with low-frequency positive-pressure ventilation and extracorporeal removal of CO2. Lancet. 1980 Aug 9;2(8189):292-4. doi: 10.1016/s0140-6736(80)90237-8.
PubMed 6105441Lim SC, Adams AB, Simonson DA, Dries DJ, Broccard AF, Hotchkiss JR, Marini JJ. Intercomparison of recruitment maneuver efficacy in three models of acute lung injury. Crit Care Med. 2004 Dec;32(12):2371-7. doi: 10.1097/01.ccm.0000147445.73344.3a.
PubMed 15599138Marini JJ. Recruitment by sustained inflation: time for a change. Intensive Care Med. 2011 Oct;37(10):1572-4. doi: 10.1007/s00134-011-2329-7. Epub 2011 Aug 20. No abstract available.
PubMed 21858521Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
PubMed 9449727Lapinsky SE, Mehta S. Bench-to-bedside review: Recruitment and recruiting maneuvers. Crit Care. 2005 Feb;9(1):60-5. doi: 10.1186/cc2934. Epub 2004 Aug 18.
PubMed 15693985
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Lung Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: A Prospective Experimental Study
- ClinicalTrials.gov ID
- NCT04935008
- Acronym / sponsor ID
- 2020/528
- Keywords
- Recruitment maneuver, Intracranial pressure, Optic Nerve Sheath Diameter, Acute respiratory distress syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 22 Jun 2021 (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.
Recruitment maneuver is used to reopen atelectasis alveoli. Positive airway pressure applied during the recruitment maneuver may increase intrathoracic pressure, resulting in hemodynamic instability, venous return disorders, and increased intracranial pressure. Our study will examine the effect of recruitment maneuver on intracranial pressure by evaluating Optic Nerve Sheath Diameter change.
Detailed description
The therapeutic goal of mechanical ventilation shifts from maintaining regular gas exchange to preventing ventilator-induced lung injury. Atelectasis aggravates lung injury by reducing the lung size available for tidal ventilation. By preventing atelectasis with Positive End Expiratory Pressure (PEEP) and recruitment maneuvers, the end-expiratory lung volume can be increased, and lung damage can be reduced.
Although the recruitment maneuver improves oxygenation and reduces mortality, especially in patients with Acute Respiratory Distress Syndrome (ARDS), adverse side effects are sometimes observed. Most important of these are the risk of barotrauma after positive airway pressure applications, increased intrathoracic pressure and hemodynamic instability, and increased intracranial pressure risk after venous return disorder.
Our study aimed to evaluate the effect of recruitment maneuver on intracranial pressure by measuring optic nerve diameter with ultrasound before and after its application in patients with ARDS with impaired oxygenation and followed up with mechanical ventilator support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all patients in mechanical ventilation
| Arm | Type | Receives |
|---|---|---|
| Effect of recruitment maneuver on intracranial pressure | Experimental | Diagnostic Test: The recruitment maneuverA recruitment maneuver will be performed in patients with decreased oxygen saturation due to atelectasis by applying 30 cm H2O positive pressure support for 30 seconds. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years
- Patients followed in the Intensive Care Unit (ICU)
- Patients on mechanical ventilation support
- Patients diagnosed with ARDS according to the Berlin criteria
- Patients with oxygen saturation (SpO2) ≤ 92%
Key exclusion criteria (5 listed)
- Younger than 18
- Patients with increased inotropic drug requirement or mean arterial pressure <65 mmHg in the last 2 hours
- Patients with intracranial hypertension
- Patients with acute coronary syndrome
- Patients with hypercapnia, pneumothorax, subcutaneous emphysema, and pneumomediastinum
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 |
|---|---|---|
| The recruitment maneuverAlso: Measurement of optic nerve sheath diameter with the help of ultrasonographyIn patients with ARDS, 30 cm H2O positive pressure support and 30 seconds recruitment maneuver will be applied. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver. Optic nerve diameter will be evaluated with a linear probe on the eyeball before and after the collection maneuver, taking a value of 3 mm from the eyeball. | Diagnostic test | Effect of recruitment maneuver on intracranial pressure |
Primary outcome
Effect of recruitment maneuver on optic nerve sheath diameter (ONSD)
Time frame: 1 minute
Change in optic nerve sheath diameter (ONSD) after the recruitment maneuver in acute respiratory distress syndrome (ARDS) patients
3 secondary outcomes
Effect of recruitment maneuver on respiratory compliance (Cdyn)
Time frame: 10 minute
Effect of recruitment maneuver on oxygen saturation (SpO2)
Time frame: 10 minute
The effect of change of respiratory compliance (Cdyn) on optic nerve sheath diameter (ONSD) after the recruitment maneuver
Time frame: 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 22357372Cortes I, Penuelas O, Esteban A. Acute respiratory distress syndrome: evaluation and management. Minerva Anestesiol. 2012 Mar;78(3):343-57.
- Background: PubMed 9445314Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. Am J Respir Crit Care Med. 1998 Jan;157(1):294-323. doi: 10.1164/ajrccm.157.1.9604014. No abstract available.
- Background: PubMed 6105441Gattinoni L, Agostoni A, Pesenti A, Pelizzola A, Rossi GP, Langer M, Vesconi S, Uziel L, Fox U, Longoni F, Kolobow T, Damia G. Treatment of acute respiratory failure with low-frequency positive-pressure ventilation and extracorporeal removal of CO2. Lancet. 1980 Aug 9;2(8189):292-4. doi: 10.1016/s0140-6736(80)90237-8.
- Background: PubMed 15599138Lim SC, Adams AB, Simonson DA, Dries DJ, Broccard AF, Hotchkiss JR, Marini JJ. Intercomparison of recruitment maneuver efficacy in three models of acute lung injury. Crit Care Med. 2004 Dec;32(12):2371-7. doi: 10.1097/01.ccm.0000147445.73344.3a.
- Background: PubMed 21858521Marini JJ. Recruitment by sustained inflation: time for a change. Intensive Care Med. 2011 Oct;37(10):1572-4. doi: 10.1007/s00134-011-2329-7. Epub 2011 Aug 20. No abstract available.
- Background: PubMed 9449727Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
- Background: PubMed 15693985Lapinsky SE, Mehta S. Bench-to-bedside review: Recruitment and recruiting maneuvers. Crit Care. 2005 Feb;9(1):60-5. doi: 10.1186/cc2934. Epub 2004 Aug 18.
- Individual participant dataSharing planned: No
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.
özgür kömürcü, 1 study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The recruitment maneuver in people with Effect of Recruitment Maneuver on Intracranial Pressure, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Mar 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of recruitment maneuver on optic nerve sheath diameter (ONSD) (time frame: 1 minute). 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 NCT04935008, which also lists 7 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 9 Mar 2022.