AtelectasisNCT04183309
Effects of Pneumoperitoneum on Dynamic Alveolar Stress-strain in Anesthetized Pediatric Patients
An observational study of Atelectasis, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
General anesthesia is associated with loss of pulmonary functional residual capacity and consequent developement of atelectasis and closure of the small airway. Infants and young children are more susceptible to this lung collapse due to their small functional residual capacity. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Measure the transpulmonary pressure in pediatric patients
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 6 Jan 2020to 29 Jul 2022
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 3 to 7 years old, schedule for abdominal laparoscopy surgery under general anesthesia with tracheal intubation
Who may be able to join
- Written Inform Consent by parents
- Programmed surgery
- Laparoscopic surgery
- Supine position
- American Society of Anesthesiologists classification: physical status I-II
Who cannot join
- Acute airway infection
- Cardiovascular or pulmonary disease
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
General anesthesia is associated with loss of pulmonary functional residual capacity and consequent developement of atelectasis and closure of the small airway. Infants and young children are more susceptible to this lung collapse due to their small functional residual capacity.
Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain inducing a local inflammatory response in atelectatic lungs areas know as ventilatory induced-lung injury (VILI). This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes children to hypoxemic episodes that can persist in the early postoperative period. During laparoscopy, pneumoperitoneum may aggravate the reduction of functional residual capacity as it generates a further increase in intra-abdominal pressure.
The increase in alveolar stress-strain cloud be reduced during pneumoperitoneum in theory, if normal functional residual capacity is restored and the transpulmonary pression is reached at the end of expiration of 0-1 cmH2O.
Read the detailed description
This is a prospective and observational study designed to measure transpulmonary pressure during pneumoperitoneum. The investigators will studied 20 mechanically ventilated pediatric patients schedule for abdominal laparoscopy surgery under general anesthesia.
Lung mechanics will be assessed during laparoscopy. Esophageal pressure will be measured by an esophageal ballon to measure transpulmonary pressure. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery. The optimal level of positive end-expiratory pressure (PEEP) if defined as the PEEP level when transpulmonary pressure remains positive during the PEEP titration trial of the recruitment maneuver.
- Conditions
- Atelectasis
- Being tested
- Measure the transpulmonary pressure in pediatric patients
- Keywords
- Children, Ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure the transpulmonary pressure in pediatric patientsOther
Esophageal pressure will be measured by an esophageal ballon to assess transpulmonary pressure during laparoscopy surgery. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. Lung ultrasound examinations will be performed at different times-points: after anesthesia induction, 10 minutes after pneumoperitoneum insufflation, and at the end of surgery. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric anesthetized patients | Pediatric anesthetized patients undergoing abdominal laparoscopy surgery (simple-arm study). Receives: Other: Measure the transpulmonary pressure in pediatric patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure measured by esophageal ballon in pediatric patients
Effect of pneumoperitoneum on transpulmonary pressure using esophageal ballon in pediatric patients schedule for abdominal laparoscopy surgery.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start6 Jan 2020
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo Tusman, MD, Study director, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183309
- Sponsor's protocol ID
- 2919/1980/2019
- Status last verified
- Feb 2022
- First submitted
- 27 Nov 2019
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pneumoperitoneum on Dynamic Alveolar Stress-strain in Anesthetized Pediatric Patients
- ClinicalTrials.gov ID
- NCT04183309
- Acronym / sponsor ID
- 2919/1980/2019
- Conditions
- Atelectasis
- Keywords
- Children, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 3 Dec 2019 (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.
General anesthesia is associated with loss of pulmonary functional residual capacity and consequent developement of atelectasis and closure of the small airway. Infants and young children are more susceptible to this lung collapse due to their small functional residual capacity.
Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain inducing a local inflammatory response in atelectatic lungs areas know as ventilatory induced-lung injury (VILI). This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes children to hypoxemic episodes that can persist in the early postoperative period. During laparoscopy, pneumoperitoneum may aggravate the reduction of functional residual capacity as it generates a further increase in intra-abdominal pressure.
The increase in alveolar stress-strain cloud be reduced during pneumoperitoneum in theory, if normal functional residual capacity is restored and the transpulmonary pression is reached at the end of expiration of 0-1 cmH2O.
Detailed description
This is a prospective and observational study designed to measure transpulmonary pressure during pneumoperitoneum. The investigators will studied 20 mechanically ventilated pediatric patients schedule for abdominal laparoscopy surgery under general anesthesia.
Lung mechanics will be assessed during laparoscopy. Esophageal pressure will be measured by an esophageal ballon to measure transpulmonary pressure. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery. The optimal level of positive end-expiratory pressure (PEEP) if defined as the PEEP level when transpulmonary pressure remains positive during the PEEP titration trial of the recruitment maneuver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric anesthetized patients | – | Other: Measure the transpulmonary pressure in pediatric patientsPediatric anesthetized patients undergoing abdominal laparoscopy surgery (simple-arm study). |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 3 to 7 years old, schedule for abdominal laparoscopy surgery under general anesthesia with tracheal intubation
Key inclusion criteria (5 listed)
- Written Inform Consent by parents
- Programmed surgery
- Laparoscopic surgery
- Supine position
- American Society of Anesthesiologists classification: physical status I-II
Key exclusion criteria (2 listed)
- Acute airway infection
- Cardiovascular or pulmonary disease
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 |
|---|---|---|
| Measure the transpulmonary pressure in pediatric patientsEsophageal pressure will be measured by an esophageal ballon to assess transpulmonary pressure during laparoscopy surgery. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. Lung ultrasound examinations will be performed at different times-points: after anesthesia induction, 10 minutes after pneumoperitoneum insufflation, and at the end of surgery. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery. | Other | Pediatric anesthetized patients |
Primary outcome
Transpulmonary pressure measured by esophageal ballon in pediatric patients
Time frame: 2 hours
Effect of pneumoperitoneum on transpulmonary pressure using esophageal ballon in pediatric patients schedule for abdominal laparoscopy surgery.
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 29 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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.
Gerardo Tusman, MD study director
Hospital Privado de Comunidad
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 Atelectasis, run by Hospital Privado de Comunidad de Mar del Plata 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 5 inclusion and 2 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 29 Aug 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 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?
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?
Transpulmonary pressure measured by esophageal ballon in pediatric patients (time frame: 2 hours). 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 29 Aug 2022.