Prone PositionPULSARNCT06020404

Prone Position in infantS/Children With Acute Respiratory Distress Syndrome

A study testing supine position and prone position in people with Prone Position and Acute Respiratory Distress Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages Up to 18 years
Conditions the study is for: Prone Position, Acute Respiratory Distress Syndrome
What is being tested?: supine position and prone position
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteItaly
Study dates: 1 Sep 2023to Sep 2025
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 Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

PaO2/FiO2 < 200 in the supine position, with a standard PEEP of 5 cmH2O;
PaCO2 <45mmHg;
Absence of history of chronic respiratory disease or heart failure or congenital heart disease (Modified Ross heart failure classification for children < II);
Not underweight infants/children defined as a low body mass index (BMI) for age;
Absence of any contraindication to PP (Appendix 1);
Written informed consent of both parents and the legal guardian.

Who cannot join

Barotrauma;
Less than 4 weeks of age (new-born physiology);
Exacerbation of asthma;
Chest trauma;
Pulmonary oedema/haemorrhage;
Severe Neutropenia (<500 WBC/mm3);

Show all 12Show fewer

Haemodynamic instability (Systolic blood pressure < 5th percentile or mean arterial pressure < 5th percentile adjusted by age);
Lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia);
Chronic kidney failure requiring dialysis before PICU admission;
Upper gastrointestinal bleeding.
Refusal to sign written informed consent of both parents and the legal guardian.

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

Giorgio Conti
Rome, 00168
Giorgio GC Conti, Professor, 0630154507, giorgio.conti@policlinicogemelli.it
Recruiting

Other trials in Italy

About this study

Official title: Physiological Effects of Prone vs. sUpine Position on Lung Recruitability in infantS/Children With Acute Respiratory Distress Syndrome

In adult patients with acute respiratory distress syndrome (ARDS), the beneficial effects of prone position (PP) have been well investigated and explored; it reduces intrapulmonary shunt (Qs/Qt) and enhances lung recruitment, modifying both lung ventilation (VA) and lung perfusion (Q) distribution, finally generating an improvement in VA/Q matching and reversing oxygenation impairment;it reduces right ventricular afterload, increase cardiac index in subjects with preload reserve and reverse acute cor pulmonale in severe ARDS patients, but in infants and children there is still a lack of clear evidence. Taken together, these effects explain why PP improves oxygenation, limits the occurrence of ventilator-induced lung injury and improves survival.

Prone position is simple to perform in infants and in some neonatal and pediatric intensive care units is already commonly accomplished. However, a detailed analysis of the respective effects of high PEEP and prone position is lacking in infants/children with ARDS, while these two tools may interfere and/or act coherently. A recent multicenter, retrospective analysis of patients with pediatric acute respiratory distress syndrome (PARDS) describes how patients managed with lower PEEP relative to FIO2 than recommended by the ARDSNet model had higher mortality, suggesting that future clinical trials targeting PEEP management in PARDS are needed. We designed a physiological study to investigate the physiological effects of prone positioning on lung recruitability in infants/children with acute respiratory distress syndrome.

Read the detailed description

Each patient meeting inclusion criteria will be evaluated for the presence of the oxygenation criterion. After neuromuscular paralysis (or apnoeic ventilation as per PICU protocol), and endotracheal suctioning, eligible patients will be ventilated for 30 min with PEEP = 5 cmH2O in the semi-recumbent position, with a tidal volume limited to 6 mL/kg and a Plateau Pressure less than 30 cmH2O. FiO2 will be titrated to obtain and SpO2 >92 % and <98 %. Afterward, arterial blood gas analysis (ABG) will be performed to compute PaO2/FiO2 ratio to confirm the presence of the inclusion and the absence of exclusion criteria.Patients showing PaO2/FiO2 ≤ 200 mmHg will be enrolled. Eligible patients will undergo the following protocol:

Verify the presence of airway closure with airway opening pressure (AOP) > PEEP5cmH2O;
PEEP will be initially set at 12 cmH2O (providing that plateau and driving pressures do not exceed 30 cmH2O and 15 cmH2O, respectively) for 40 minutes to stabilize lung volumes; afterwards, respiratory mechanics will be assessed through standard occlusions and arterial blood gases will be analyzed. Subsequently, a 4-steps decremental PEEP trial (PEEP 12 to 10 to 8 to 5 cmH2O) will be conducted. Each PEEP step will last 8 minutes, and all other ventilator settings will remain unchanged throughout the procedure. At the end of each PEEP step respiratory mechanics will be assessed by the ventilator through 1-second end-inspiratory and end-expiratory holds: plateau pressure [Pplat] and total PEEP [PEEPtot] will be measured, and driving pressure [ΔP=Pplat-PEEPtot] and respiratory system compliance [Crs = VT/ΔP] will be assessed;
End-expiratory lung impedance (EELI) will be measured by electrical impedance tomography (EIT)

Conditions: Prone Position, Acute Respiratory Distress Syndrome
Being tested: supine position, prone position
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.

supine positionProcedure or surgery
At the end of the PEEP trial (i.e. at PEEP 5 cmH2O), patients will lay in the supine position for 15 minutes arterial blood gases will be performed and then a one-breath derecruitment maneuver (5-second exhalation, respiratory rate < 8 bpm) from PEEP 5 cmH2O to 0 cmH2O will be conducted to assess baseline functional residual capacity (FRC), defined as the EELI measured at 0 PEEP.
prone positionProcedure or surgery
After the supine step, each enrolled patient will be placed in the prone position for 1 hour.
For safety reasons, enteral feeding will be interrupted 30 minutes before prone positioning and re-established after the study ending.
During pronation FiO2 will be increased up to 80% and then gradually decreased to the baseline value within the first 30 minutes of prone positioning. After 30 minutes of PEEP 12 cmH2O (provided that plateau and driving pressures did not exceed 30 cmH2O and 15 cmH2O, respectively) to stabilize lung volumes, the same measurements applied for the supine step will be performed. Any further modifications in the MV settings will be discouraged over the entire course of the study; nonetheless, if needed to achieve the SpO2 target, an increase in FiO2 will be allowed and recorded.
In case of sudden worsening of the oxygenation impairment or haemodynamic, 100% FiO2 will be set, and the patient will be promptly positioned in the supine semi-recumbent position.

Study groups in NCT06020404
Study group	Role	What they receive
Controls	Experimental	Eligible patients will undergo the experimental protocol. Receives: Procedure: supine position; Procedure: prone position
Patients	Experimental	Eligible patients will undergo the experimental protocol. Receives: Procedure: supine position; Procedure: prone position

What is being measured

The primary outcome is the main question the study is designed to answer.

effect of prone positioning on lung recruitability
PaO2/FiO2 ratio
Measured: at the end of the supine and prone position

Secondary outcomes (9)

difference in gas exchanges
PaO2/FiO2, PaCO2, PaO2
Measured: at the end of the supine and prone position
ventilatory ratio
minute ventilation (ml/min) × PaCO2 (mmHg)]/(predicted body weight × 100 × 37.5)
Measured: at the end of the supine and prone position
global impedance-derived End-expiratory lung volume
effects of prone position on End-expiratory lung volume, measured with electrical impedance tomography
Measured: at the end of the supine and prone position
regional impedance-derived End-expiratory lung volume
effects of prone position on End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Measured: at the end of the supine and prone position
tidal volume distribution
effect of prone position on % tidal volume distribution in the four regions of the lung (ventral, mid-ventral, mid-dorsal, dorsal), explored with electrical impedance tomography
Measured: at the end of the supine and prone position
global impedance-derived lung dynamic strain
change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography
Measured: at the end of the supine and prone position
regional impedance-derived lung dynamic strain
change in impedance due to tidal volume / end expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Measured: at the end of the supine and prone position
number of displacements of the endotracheal tube during prone position
safety endpoint
Measured: 2 hours
number of oxygen desaturations during prone position
safety endpoint
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2023Sep 2025

First posted31 Aug 2023
Study start1 Sep 2023
Primary completionSep 2024 (estimated)
Study completionSep 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Prone PositionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Model description: 2x2 cross-over design
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06020404
Sponsor's protocol ID: 5922
Acronym: PULSAR
Status last verified: Aug 2023
First submitted: 28 Aug 2023
Last updated: 23 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PubMed 23688302
Pelosi P, Tubiolo D, Mascheroni D, Vicardi P, Crotti S, Valenza F, Gattinoni L. Effects of the prone position on respiratory mechanics and gas exchange during acute lung injury. Am J Respir Crit Care Med. 1998 Feb;157(2):387-93. doi: 10.1164/ajrccm.157.2.97-04023.
PubMed 9476848
Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
PubMed 24134414
Curley MA, Hibberd PL, Fineman LD, Wypij D, Shih MC, Thompson JE, Grant MJ, Barr FE, Cvijanovich NZ, Sorce L, Luckett PM, Matthay MA, Arnold JH. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.
PubMed 16014597
Lupton-Smith A, Argent A, Rimensberger P, Frerichs I, Morrow B. Prone Positioning Improves Ventilation Homogeneity in Children With Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2017 May;18(5):e229-e234. doi: 10.1097/PCC.0000000000001145.
PubMed 28328787
Bhandari AP, Nnate DA, Vasanthan L, Konstantinidis M, Thompson J. Positioning for acute respiratory distress in hospitalised infants and children. Cochrane Database Syst Rev. 2022 Jun 6;6(6):CD003645. doi: 10.1002/14651858.CD003645.pub4.
PubMed 35661343
Fineman LD, LaBrecque MA, Shih MC, Curley MA. Prone positioning can be safely performed in critically ill infants and children. Pediatr Crit Care Med. 2006 Sep;7(5):413-22. doi: 10.1097/01.PCC.0000235263.86365.B3.
PubMed 16885792
Khemani RG, Parvathaneni K, Yehya N, Bhalla AK, Thomas NJ, Newth CJL. Positive End-Expiratory Pressure Lower Than the ARDS Network Protocol Is Associated with Higher Pediatric Acute Respiratory Distress Syndrome Mortality. Am J Respir Crit Care Med. 2018 Jul 1;198(1):77-89. doi: 10.1164/rccm.201707-1404OC.
PubMed 29373802
Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.
PubMed 30211618
Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC.
PubMed 36378814
Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.
PubMed 23050520
Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
PubMed 31577153
Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.
PubMed 30360753
Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
PubMed 19255741
Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.
PubMed 30448014

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Prone Position trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiological Effects of Prone vs. sUpine Position on Lung Recruitability in infantS/Children With Acute Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT06020404
Acronym / sponsor ID: PULSAR / 5922
Conditions: Prone Position, Acute Respiratory Distress Syndrome
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 15 participants (estimated)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: Sep 2024 (estimated)
Study completion: Sep 2025 (estimated)
First posted: 31 Aug 2023 (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.

Detailed description

Verify the presence of airway closure with airway opening pressure (AOP) > PEEP5cmH2O;
PEEP will be initially set at 12 cmH2O (providing that plateau and driving pressures do not exceed 30 cmH2O and 15 cmH2O, respectively) for 40 minutes to stabilize lung volumes; afterwards, respiratory mechanics will be assessed through standard occlusions and arterial blood gases will be analyzed. Subsequently, a 4-steps decremental PEEP trial (PEEP 12 to 10 to 8 to 5 cmH2O) will be conducted. Each PEEP step will last 8 minutes, and all other ventilator settings will remain unchanged throughout the procedure. At the end of each PEEP step respiratory mechanics will be assessed by the ventilator through 1-second end-inspiratory and end-expiratory holds: plateau pressure [Pplat] and total PEEP [PEEPtot] will be measured, and driving pressure [ΔP=Pplat-PEEPtot] and respiratory system compliance [Crs = VT/ΔP] will be assessed;
End-expiratory lung impedance (EELI) will be measured by electrical impedance tomography (EIT)

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 2x2 cross-over design

Arm	Type	Receives
Controls	Experimental	Procedure: supine position, Procedure: prone positionEligible patients will undergo the experimental protocol.
Patients	Experimental	Procedure: supine position, Procedure: prone positionEligible patients will undergo the experimental protocol.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

PaO2/FiO2 < 200 in the supine position, with a standard PEEP of 5 cmH2O;
PaCO2 <45mmHg;
Absence of history of chronic respiratory disease or heart failure or congenital heart disease (Modified Ross heart failure classification for children < II);
Not underweight infants/children defined as a low body mass index (BMI) for age;
Absence of any contraindication to PP (Appendix 1);

Key exclusion criteria (12 listed)

Barotrauma;
Less than 4 weeks of age (new-born physiology);
Exacerbation of asthma;
Chest trauma;
Pulmonary oedema/haemorrhage;

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
supine positionAt the end of the PEEP trial (i.e. at PEEP 5 cmH2O), patients will lay in the supine position for 15 minutes arterial blood gases will be performed and then a one-breath derecruitment maneuver (5-second exhalation, respiratory rate < 8 bpm) from PEEP 5 cmH2O to 0 cmH2O will be conducted to assess baseline functional residual capacity (FRC), defined as the EELI measured at 0 PEEP.	Procedure or surgery	Controls, Patients
prone positionAfter the supine step, each enrolled patient will be placed in the prone position for 1 hour. For safety reasons, enteral feeding will be interrupted 30 minutes before prone positioning and re-established after the study ending. During pronation FiO2 will be increased up to 80% and then gradually decreased to the baseline value within the first 30 minutes of prone positioning. After 30 minutes of PEEP 12 cmH2O (provided that plateau and driving pressures did not exceed 30 cmH2O and 15 cmH2O, respectively) to stabilize lung volumes, the same measurements applied for the supine step will be performed. Any further modifications in the MV settings will be discouraged over the entire course of the study; nonetheless, if needed to achieve the SpO2 target, an increase in FiO2 will be allowed and recorded. In case of sudden worsening of the oxygenation impairment or haemodynamic, 100% FiO2 will be set, and the patient will be promptly positioned in the supine semi-recumbent position.	Procedure or surgery	Controls, Patients

Primary outcome

effect of prone positioning on lung recruitability
Time frame: at the end of the supine and prone position
PaO2/FiO2 ratio

9 secondary outcomes

difference in gas exchanges
Time frame: at the end of the supine and prone position
ventilatory ratio
Time frame: at the end of the supine and prone position
global impedance-derived End-expiratory lung volume
Time frame: at the end of the supine and prone position
regional impedance-derived End-expiratory lung volume
Time frame: at the end of the supine and prone position
tidal volume distribution
Time frame: at the end of the supine and prone position
global impedance-derived lung dynamic strain
Time frame: at the end of the supine and prone position
regional impedance-derived lung dynamic strain
Time frame: at the end of the supine and prone position
number of displacements of the endotracheal tube during prone position
Time frame: 2 hours
number of oxygen desaturations during prone position
Time frame: 2 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Results publication: PubMed 23688302Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
Results publication: PubMed 9476848Pelosi P, Tubiolo D, Mascheroni D, Vicardi P, Crotti S, Valenza F, Gattinoni L. Effects of the prone position on respiratory mechanics and gas exchange during acute lung injury. Am J Respir Crit Care Med. 1998 Feb;157(2):387-93. doi: 10.1164/ajrccm.157.2.97-04023.
Results publication: PubMed 24134414Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
Results publication: PubMed 16014597Curley MA, Hibberd PL, Fineman LD, Wypij D, Shih MC, Thompson JE, Grant MJ, Barr FE, Cvijanovich NZ, Sorce L, Luckett PM, Matthay MA, Arnold JH. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.
Results publication: PubMed 28328787Lupton-Smith A, Argent A, Rimensberger P, Frerichs I, Morrow B. Prone Positioning Improves Ventilation Homogeneity in Children With Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2017 May;18(5):e229-e234. doi: 10.1097/PCC.0000000000001145.
Results publication: PubMed 35661343Bhandari AP, Nnate DA, Vasanthan L, Konstantinidis M, Thompson J. Positioning for acute respiratory distress in hospitalised infants and children. Cochrane Database Syst Rev. 2022 Jun 6;6(6):CD003645. doi: 10.1002/14651858.CD003645.pub4.
Results publication: PubMed 16885792Fineman LD, LaBrecque MA, Shih MC, Curley MA. Prone positioning can be safely performed in critically ill infants and children. Pediatr Crit Care Med. 2006 Sep;7(5):413-22. doi: 10.1097/01.PCC.0000235263.86365.B3.
Results publication: PubMed 29373802Khemani RG, Parvathaneni K, Yehya N, Bhalla AK, Thomas NJ, Newth CJL. Positive End-Expiratory Pressure Lower Than the ARDS Network Protocol Is Associated with Higher Pediatric Acute Respiratory Distress Syndrome Mortality. Am J Respir Crit Care Med. 2018 Jul 1;198(1):77-89. doi: 10.1164/rccm.201707-1404OC.
Results publication: PubMed 30211618Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.
Results publication: PubMed 36378814Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC.
Results publication: PubMed 23050520Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.
Results publication: PubMed 31577153Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
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.

Giorgio Conti

Rome, Italy

0630154507

giorgio.conti@policlinicogemelli.it

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 12 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 Feb 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect of prone positioning on lung recruitability (time frame: at the end of the supine and prone 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 NCT06020404, which also lists 15 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 Feb 2024.