Positive End-expiratory Pressure (PEEP)NCT07233304
Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation
An observational study of Positive End-expiratory Pressure (PEEP) and Oxygenation Index, run by Hospital de Alta Complejidad en Red at 1 site in Argentina.
Trial summary
The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Positive End-expiratory Pressure (PEEP), Oxygenation Index, Pediatric Intensive Care Unit
- What is being tested?
- Alveolar Opening Maneuver and PEEP Titration (AOM+P)
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteArgentina
- Study dates
- 18 Aug 2025to Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients under 14 years of age admitted to the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner
Who may be able to join
- Patients under 14 years of age admitted to the HCANK PICU
- More than 4 hours of invasive mechanical ventilation (IMV)
- An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5
- Indication for ARM and PEEP as determined by the treating team
Who cannot join
- Predicted body weight (PBW) >45.5 kg
- Recent pulmonary resection surgery (<7 days)
- Presence of broncho-pleural fistula or peri-tube leak >25% of the tidal volume
- Hemoglobin decline <7 g/dL
- Patients with congenital or acquired heart diseases with significant intracardiac shunt.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Cuenca Alta Néstor Kirchner
Canuelas, Buenos Aires, B1814
About this study
Official title: Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome
The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.
Read the detailed description
Objective
To analyze the overall incidence of complications associated with alveolar opening maneuvers and PEEP in pediatric patients with respiratory distress syndrome.
Materials and Methods
Study setting A prospective cohort study will be conducted between April and September in the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner (HCANK).
Sample All patients meeting the eligibility criteria will be included. An estimated total of 143 maneuvers involving alveolar opening maneuversand PEEP are to be analyzed, as these procedures are part of the standard care in managing ventilated patients with ARDS and are included in the institutional protocol (see Appendix).
Inclusion criteria:
- Patients under 14 years of age admitted to the HCANK PICU
- More than 4 hours of invasive mechanical ventilation (IMV)
- An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5
- Indication for alveolar opening maneuvers and PEEP as determined by the treating team
Exclusion criteria:
- Predicted body weight (PBW) >45.5 kg
- Recent pulmonary resection surgery (<7 days)
- Presence of broncho-pleural fistula or peri-tube leak >25% of the tidal volume
- Hemoglobin decline <7 g/dL
- Patients with congenital or acquired heart diseases with significant intracardiac shunt
Variables:
Outcome variable:
- Overall incidence of complications related to alveolar opening maneuvers and PEEP
Procedure Once patients are included, demographic, clinical, and relevant background data will be recorded in a dedicated data sheet. Following this, study evaluators will record baseline clinical data from the multiparameter monitor prior to performing the alveolar opening maneuvers and PEEP procedures. Relevant values will be obtained from the advanced monitoring sheet completed by the treating team.
During the alveolar opening maneuvers and PEEP procedures, intra-procedural complications will be noted, and monitoring will continue for 4 hours after the procedure to observe for any complications that develop.
If, due to intercurrences or the treating team's decision, the alveolar opening maneuvers and PEEP need to be repeated before 4 hours, monitoring will still continue for 4 hours after the last maneuver.
Statistical Analysis Categorical variables will be described using absolute numbers and percentages of the total, while continuous variables will be expressed using measures of central tendency and dispersion or position, depending on their distribution.
The Kolmogorov-Smirnov test will be used as a goodness-of-fit test to determine the distribution of numerical variables.
To address the objective, the overall incidence of complications will be calculated, with estimates and 95% confidence intervals provided.
Data analysis will be performed using IBM SPSS Windows version 25.0 (IBM Corp., Armonk, NY, USA), R version 3.6.3 (R Core Team, 2020), and the ggplot2 package version 3.3.2 (Wickham, 2016) for graph creation.
Sample size calculation The calculation assumes a null hypothesis where the incidence of complications after alveolar opening maneuvers and PEEP is 5%, based on previously reported data indicating a lower rate of complications.
The alternative hypothesis posits that the incidence of complications related to alveolar opening maneuvers and PEEP is less than 5%.
A total of 143 maneuvers are planned to be recruited according to the sample size calculation based on these hypothesized values.
- Conditions
- Positive End-expiratory Pressure (PEEP), Oxygenation Index, Pediatric Intensive Care Unit, Pediatric Acute Lung Injury, Respiratory Distress Syndrome, Pediatric, Complication
- Being tested
- Alveolar Opening Maneuver and PEEP Titration (AOM+P)
- 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.
Alveolar Opening Maneuver and PEEP Titration (AOM+P)Procedure or surgery
Also called Alveolar Opening Protocol, PEEP Titration Procedure, AOM+P Institutional Protocol
Standardized ventilatory procedure performed in pediatric patients under invasive mechanical ventilation with acute respiratory distress syndrome (PARDS). The intervention consists of a controlled alveolar opening maneuver with stepwise PEEP increments up to a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by a decremental PEEP titration to determine the optimal PEEP level based on driving pressure and oxygenation response. The procedure is performed once clinically indicated, under continuous hemodynamic and oxygen monitoring, according to the institutional safety protocol.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar Opening Maneuver and PEEP Titration (AOM+P) | Patients under invasive mechanical ventilation for pediatric acute respiratory distress syndrome (PARDS) who undergo a standardized alveolar opening maneuver followed by decremental PEEP titration according to institutional protocol. The maneuver consists of stepwise increases in PEEP until reaching a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by decremental PEEP titration to determine the optimal level based on driving pressure and oxygen saturation. The procedure is performed once clinically indicated, with continuous hemodynamic and oxygenation monitoring. Receives: Procedure: Alveolar Opening Maneuver and PEEP Titration (AOM+P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of complications related to the alveolar opening maneuver and PEEP titration
The number and proportion of patients who develop any adverse event directly associated with the alveolar opening maneuver or PEEP titration within 4 hours after the procedure. Complications may include hemodynamic instability (e.g., hypotension, bradycardia), oxygen desaturation, barotrauma (such as pneumothorax), or cardiac arrhythmias observed during or after the intervention.
Measured: 4 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start18 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive End-expiratory Pressure (PEEP)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 143 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital de Alta Complejidad en Red
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belen Castelli, Hospital de Alta Complejidad en Red
- Investigators
- Jose Garcia Urrutia, BCS, Principal investigator, Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, ArgentinaBelen Castelli, BCS, Principal investigator, Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233304
- Sponsor's protocol ID
- 080-2025-EO
- Status last verified
- Jun 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07233304
- Acronym / sponsor ID
- 080-2025-EO
- Conditions
- Positive End-expiratory Pressure (PEEP), Oxygenation Index, Pediatric Intensive Care Unit, Pediatric Acute Lung Injury, Respiratory Distress Syndrome, Pediatric, Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Hospital de Alta Complejidad en RedUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Nov 2025 (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 objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.
Detailed description
Objective
To analyze the overall incidence of complications associated with alveolar opening maneuvers and PEEP in pediatric patients with respiratory distress syndrome.
Materials and Methods
Study setting A prospective cohort study will be conducted between April and September in the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner (HCANK).
Sample All patients meeting the eligibility criteria will be included. An estimated total of 143 maneuvers involving alveolar opening maneuversand PEEP are to be analyzed, as these procedures are part of the standard care in managing ventilated patients with ARDS and are included in the institutional protocol (see Appendix).
Inclusion criteria:
- Patients under 14 years of age admitted to the HCANK PICU
- More than 4 hours of invasive mechanical ventilation (IMV)
- An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5
- Indication for alveolar opening maneuvers and PEEP as determined by the treating team
Exclusion criteria:
- Predicted body weight (PBW) >45.5 kg
- Recent pulmonary resection surgery (<7 days)
- Presence of broncho-pleural fistula or peri-tube leak >25% of the tidal volume
- Hemoglobin decline <7 g/dL
- Patients with congenital or acquired heart diseases with significant intracardiac shunt
Variables:
Outcome variable:
- Overall incidence of complications related to alveolar opening maneuvers and PEEP
Procedure Once patients are included, demographic, clinical, and relevant background data will be recorded in a dedicated data sheet. Following this, study evaluators will record baseline clinical data from the multiparameter monitor prior to performing the alveolar opening maneuvers and PEEP procedures. Relevant values will be obtained from the advanced monitoring sheet completed by the treating team.
During the alveolar opening maneuvers and PEEP procedures, intra-procedural complications will be noted, and monitoring will continue for 4 hours after the procedure to observe for any complications that develop.
If, due to intercurrences or the treating team's decision, the alveolar opening maneuvers and PEEP need to be repeated before 4 hours, monitoring will still continue for 4 hours after the last maneuver.
Statistical Analysis Categorical variables will be described using absolute numbers and percentages of the total, while continuous variables will be expressed using measures of central tendency and dispersion or position, depending on their distribution.
The Kolmogorov-Smirnov test will be used as a goodness-of-fit test to determine the distribution of numerical variables.
To address the objective, the overall incidence of complications will be calculated, with estimates and 95% confidence intervals provided.
Data analysis will be performed using IBM SPSS Windows version 25.0 (IBM Corp., Armonk, NY, USA), R version 3.6.3 (R Core Team, 2020), and the ggplot2 package version 3.3.2 (Wickham, 2016) for graph creation.
Sample size calculation The calculation assumes a null hypothesis where the incidence of complications after alveolar opening maneuvers and PEEP is 5%, based on previously reported data indicating a lower rate of complications.
The alternative hypothesis posits that the incidence of complications related to alveolar opening maneuvers and PEEP is less than 5%.
A total of 143 maneuvers are planned to be recruited according to the sample size calculation based on these hypothesized values.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alveolar Opening Maneuver and PEEP Titration (AOM+P) | – | Procedure: Alveolar Opening Maneuver and PEEP Titration (AOM+P)Patients under invasive mechanical ventilation for pediatric acute respiratory distress syndrome (PARDS) who undergo a standardized alveolar opening maneuver followed by decremental PEEP titration according to institutional protocol. The maneuver consists of stepwise increases in PEEP until reaching a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by decremental PEEP titration to determine the optimal level based on driving pressure and oxygen saturation. The procedure is performed once clinically indicated, with continuous hemodynamic and oxygenation monitoring. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients under 14 years of age admitted to the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner
Key inclusion criteria (4 listed)
- Patients under 14 years of age admitted to the HCANK PICU
- More than 4 hours of invasive mechanical ventilation (IMV)
- An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5
- Indication for ARM and PEEP as determined by the treating team
Key exclusion criteria (5 listed)
- Predicted body weight (PBW) >45.5 kg
- Recent pulmonary resection surgery (<7 days)
- Presence of broncho-pleural fistula or peri-tube leak >25% of the tidal volume
- Hemoglobin decline <7 g/dL
- Patients with congenital or acquired heart diseases with significant intracardiac shunt.
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 |
|---|---|---|
| Alveolar Opening Maneuver and PEEP Titration (AOM+P)Also: Alveolar Opening Protocol, PEEP Titration Procedure, AOM+P Institutional ProtocolStandardized ventilatory procedure performed in pediatric patients under invasive mechanical ventilation with acute respiratory distress syndrome (PARDS). The intervention consists of a controlled alveolar opening maneuver with stepwise PEEP increments up to a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by a decremental PEEP titration to determine the optimal PEEP level based on driving pressure and oxygenation response. The procedure is performed once clinically indicated, under continuous hemodynamic and oxygen monitoring, according to the institutional safety protocol. | Procedure or surgery | Alveolar Opening Maneuver and PEEP Titration (AOM+P) |
Primary outcome
Overall incidence of complications related to the alveolar opening maneuver and PEEP titration
Time frame: 4 hours post-procedure
The number and proportion of patients who develop any adverse event directly associated with the alveolar opening maneuver or PEEP titration within 4 hours after the procedure. Complications may include hemodynamic instability (e.g., hypotension, bradycardia), oxygen desaturation, barotrauma (such as pneumothorax), or cardiac arrhythmias observed during or after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Positive End-expiratory Pressure (PEEP)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Congenital Heart Disease, Cardiopulmonary Bypass
RecruitingPhase 1/2
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Congenital Heart Disease, Cardiopulmonary Bypass
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.
Jose Garcia Urrutia, BCS principal investigator
Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina
Belen Castelli, BCS principal investigator
Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina
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 Positive End-expiratory Pressure (PEEP) and Oxygenation Index, run by Hospital de Alta Complejidad en Red at 1 site in Argentina.
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 4 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Argentina. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Belén B castelli, BCS (+54 2227442582, investigacion@hospitalcuencaalta.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of complications related to the alveolar opening maneuver and PEEP titration (time frame: 4 hours post-procedure). 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 18 Nov 2025.