Respiratory InsufficiencyNCT01070654
Inflammatory Effects of a Lung Recruitment Manoeuvre
A study testing 40/30 recruitment manoeuvre and continuous positive airway pressure (CPAP) in people with Respiratory Insufficiency and Respiratory Distress Syndrome, Adult, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Distress Syndrome, Adult
- What is being tested?
- 40/30 recruitment manoeuvre and continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical Ventilation
- Arterial catheter inserted
- Hypoxemic respiratory failure (Pa02/FiO2 <300)
- Radiological evidence of atelectasis or pulmonary infiltrates in the CXR
- Informed consent
Who cannot join
- Elevated intracranial pressure >25 mmHg
- Bronchopulmonary fistula
- Emphysema
- Kidney or Liver failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56126
Francesco Forfori, +39050993234, forforiden@libero.it
Giuseppe Mancino
About this study
Official title: Prospective, Open, Uncontrolled, Non-randomized and Monocentric Trial on the Efficacy and the Inflammatory Effects of a Lung Recruitment Manoeuvre in Mechanical Ventilated Patients With Respiratory Failure
Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung.
This study aims to determine the safety and efficacy of a recruitment manoeuvre, by considering its impact on gas exchange, hemodynamics and on the release of systemic inflammatory mediators.
Read the detailed description
This prospective study will analyse the effects of a single recruitment manoeuvre in critically ill patients. Subjects will be mechanically ventilated patients needing alveolar RMs. After a period of stable lung protective approach ventilation, they will receive the "40/30" RM; lung mechanics, gas exchange, hemodynamics and plasmatic concentration of inflammatory mediators will be obtained before and after the RM. An ultrasound score, established from the lung aeration status of upper and lower parts of anterior and lateral chest wall, will also be calculated before and after the manoeuvre.In selected patients cytokine release in the bronchoalveolar lavage will be measured as well.
- Being tested
- 40/30 recruitment manoeuvre, continuous positive airway pressure (CPAP)
- Keywords
- ARDS, Recruitment Manoeuvres, PEEP, Cytokines, Respiratory Insufficiency
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40/30 recruitment manoeuvreProcedure or surgery
Also called Recruitment Manoeuvres, ARDS open lung strategy, PEEP
The ventilator will be switched to the continuous positive airway pressure (CPAP) mode and the pressure will be increased to 40 cmH20 for 30 seconds.
continuous positive airway pressure (CPAP)Device
continuous positive airway pressure (CPAP)
| Study group | Role | What they receive |
|---|---|---|
| 40/30 Recruitment Manoeuvre | Experimental | Patients with respiratory failure that will be first ventilated for 30 minutes according to standardized baseline protective ventilation and after that will receive the recruitment manoeuvre Receives: Procedure: 40/30 recruitment manoeuvre; Device: continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
Measured: T0 (baseline), T4 (3 hrs), T5 (12 hrs)
Plasmatic concentration of Nitric Oxide
Measured: T0 (baseline), T6 (24 hrs)
Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)
Measured: T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs)
Echographic score of lung aeration
Measured: T0 (baseline), T2 (1 hr), T4 (3 hrs)
Chest X-Ray
Measured: T6 (24 hrs)
Secondary outcomes (1)
Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage
Measured: T0 (baseline), T4 (3 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Forfori, Principal investigator, UO IV Anestesia e Rianimazione
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070654
- Sponsor's protocol ID
- RM0910
- Other IDs
- RMSGMFF
- Status last verified
- Feb 2010
- First submitted
- 16 Feb 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Uncontrolled, Non-randomized and Monocentric Trial on the Efficacy and the Inflammatory Effects of a Lung Recruitment Manoeuvre in Mechanical Ventilated Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT01070654
- Acronym / sponsor ID
- RM0910
- Keywords
- ARDS, Recruitment Manoeuvres, PEEP, Cytokines, Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Feb 2010 (estimated)
- 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 manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung.
This study aims to determine the safety and efficacy of a recruitment manoeuvre, by considering its impact on gas exchange, hemodynamics and on the release of systemic inflammatory mediators.
Detailed description
This prospective study will analyse the effects of a single recruitment manoeuvre in critically ill patients. Subjects will be mechanically ventilated patients needing alveolar RMs. After a period of stable lung protective approach ventilation, they will receive the "40/30" RM; lung mechanics, gas exchange, hemodynamics and plasmatic concentration of inflammatory mediators will be obtained before and after the RM. An ultrasound score, established from the lung aeration status of upper and lower parts of anterior and lateral chest wall, will also be calculated before and after the manoeuvre.In selected patients cytokine release in the bronchoalveolar lavage will be measured as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 40/30 Recruitment Manoeuvre | Experimental | Procedure: 40/30 recruitment manoeuvre, Device: continuous positive airway pressure (CPAP)Patients with respiratory failure that will be first ventilated for 30 minutes according to standardized baseline protective ventilation and after that will receive the recruitment manoeuvre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mechanical Ventilation
- Arterial catheter inserted
- Hypoxemic respiratory failure (Pa02/FiO2 <300)
- Radiological evidence of atelectasis or pulmonary infiltrates in the CXR
- Informed consent
Key exclusion criteria (4 listed)
- Elevated intracranial pressure >25 mmHg
- Bronchopulmonary fistula
- Emphysema
- Kidney or Liver failure
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 |
|---|---|---|
| 40/30 recruitment manoeuvreAlso: Recruitment Manoeuvres, ARDS open lung strategy, PEEPThe ventilator will be switched to the continuous positive airway pressure (CPAP) mode and the pressure will be increased to 40 cmH20 for 30 seconds. | Procedure or surgery | 40/30 Recruitment Manoeuvre |
| continuous positive airway pressure (CPAP)continuous positive airway pressure (CPAP) | Device | 40/30 Recruitment Manoeuvre |
Primary outcome
Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
Time frame: T0 (baseline), T4 (3 hrs), T5 (12 hrs)
Plasmatic concentration of Nitric Oxide
Time frame: T0 (baseline), T6 (24 hrs)
Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)
Time frame: T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs)
Echographic score of lung aeration
Time frame: T0 (baseline), T2 (1 hr), T4 (3 hrs)
Chest X-Ray
Time frame: T6 (24 hrs)
1 secondary outcome
Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage
Time frame: T0 (baseline), T4 (3 hrs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Francesco Forfori principal investigator
UO IV Anestesia e Rianimazione
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40/30 recruitment manoeuvre and continuous positive airway pressure (CPAP) in people with Respiratory Insufficiency and Respiratory Distress Syndrome, Adult, run by Azienda Ospedaliero, Universitaria Pisana 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 5 inclusion and 4 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 7 Jul 2010. 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?
Contact Francesco Forfori (+39050993234, forforiden@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa (time frame: T0 (baseline), T4 (3 hrs), T5 (12 hrs)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2010.