AtelectasisNCT02824146
Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery
A study testing Lung recruitment maneuver in people with Atelectasis, run by Hospital Privado de Comunidad de Mar del Plata.
Trial summary
Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery. Read more about this study
- Who is it for?
- Ages 6 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- Lung recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to May 2016
- 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 6 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent by parents.
- Patients aged 6 months to 7 years old
- Scheduled for abdominal laparoscopic surgery
- American Society of Anesthesiologists classification: physical status I-II
Who cannot join
- Acute airway infection
- Cardiovascular and or pulmonary disease
- Previous thoracic procedure
About this study
Official title: Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Abdominal Laparoscopic Surgery
Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery. Such anesthesia-related atelectasis has a number of negative clinical consequences such as the impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for ventilator-associated lung injury. The adjustment of ventilator settings for preventing the occurrence of atelectasis and for reducing pulmonary complications remains controversial.
Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including atelectasis of different origins. LUS has demonstrated its high sensitivity and specificity for diagnosing anesthesia-induced atelectasis in children.
Read the detailed description
Compare lung aeration between two different mechanical ventilation strategies (protective mechanical ventilation and recruitment maneuvers) in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four-point-aeration score to assess the lung aeration.
- Conditions
- Atelectasis
- Being tested
- Lung recruitment maneuver
- Keywords
- atelectasis, children, lung ultrasound, lung recruitment
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung recruitment maneuverOther
The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (15 cmH2O of PEEP + 15 cmH2O of driving pressure) for 10 breaths.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients received standard protective mechanical ventilation during all surgery, with tidal volumen 6 ml/kg and positive end-expiratory pressure (PEEP) level of 5 (centimeter of water) cmH2O. |
| Recruitment maneuver group | Experimental | Patient received a lung recruitment maneuver after pneumoperitoneum insufflation.
The recruitment maneuver consists in 10 breaths at 30/15 cmH2O of plateau pressure and PEEP, respectively. Then, the ventilatory settings back to protective ventilation but adding 8 cmH2O of PEEP to keep the lungs open. Receives: Other: Lung recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score to assess the lung aeration
Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score (0: normal lung aeration, 1: moderate loss of lung aeration, 2: severe loss of lung aeration, 3: complete loss of lung aeration and lung consolidation).
Measured: intraoperative
Secondary outcomes (1)
Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 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
- Cecilia Maria Acosta, MD, Principal investigator, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824146
- Sponsor's protocol ID
- Hospital Privado de Comunidad
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
PubMed 20851923Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
PubMed 24662376Serafini G, Cornara G, Cavalloro F, Mori A, Dore R, Marraro G, Braschi A. Pulmonary atelectasis during paediatric anaesthesia: CT scan evaluation and effect of positive endexpiratory pressure (PEEP). Paediatr Anaesth. 1999;9(3):225-8. doi: 10.1046/j.1460-9592.1999.00340.x.
PubMed 10320601Tusman G, Bohm SH, Vazquez de Anda GF, do Campo JL, Lachmann B. 'Alveolar recruitment strategy' improves arterial oxygenation during general anaesthesia. Br J Anaesth. 1999 Jan;82(1):8-13. doi: 10.1093/bja/82.1.8.
PubMed 10325828Acosta CM, Sara T, Carpinella M, Volpicelli G, Ricci L, Poliotto S, Abrego D, Gonorazky S, Bohm SH, Tusman G. Lung recruitment prevents collapse during laparoscopy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):573-580. doi: 10.1097/EJA.0000000000000761.
PubMed 29278555
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Abdominal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02824146
- Acronym / sponsor ID
- Hospital Privado de Comunidad
- Conditions
- Atelectasis
- Keywords
- atelectasis, children, lung ultrasound, lung recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Jul 2016 (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.
Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery. Such anesthesia-related atelectasis has a number of negative clinical consequences such as the impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for ventilator-associated lung injury. The adjustment of ventilator settings for preventing the occurrence of atelectasis and for reducing pulmonary complications remains controversial.
Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including atelectasis of different origins. LUS has demonstrated its high sensitivity and specificity for diagnosing anesthesia-induced atelectasis in children.
Detailed description
Compare lung aeration between two different mechanical ventilation strategies (protective mechanical ventilation and recruitment maneuvers) in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four-point-aeration score to assess the lung aeration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients received standard protective mechanical ventilation during all surgery, with tidal volumen 6 ml/kg and positive end-expiratory pressure (PEEP) level of 5 (centimeter of water) cmH2O. |
| Recruitment maneuver group | Experimental | Other: Lung recruitment maneuverPatient received a lung recruitment maneuver after pneumoperitoneum insufflation. The recruitment maneuver consists in 10 breaths at 30/15 cmH2O of plateau pressure and PEEP, respectively. Then, the ventilatory settings back to protective ventilation but adding 8 cmH2O of PEEP to keep the lungs open. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent by parents.
- Patients aged 6 months to 7 years old
- Scheduled for abdominal laparoscopic surgery
- American Society of Anesthesiologists classification: physical status I-II
Key exclusion criteria (3 listed)
- Acute airway infection
- Cardiovascular and or pulmonary disease
- Previous thoracic procedure
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 |
|---|---|---|
| Lung recruitment maneuverThe lung recruitment maneuver consists in a brief and controlled increment in airways pressure (15 cmH2O of PEEP + 15 cmH2O of driving pressure) for 10 breaths. | Other | Recruitment maneuver group |
Primary outcome
Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score to assess the lung aeration
Time frame: intraoperative
Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score (0: normal lung aeration, 1: moderate loss of lung aeration, 2: severe loss of lung aeration, 3: complete loss of lung aeration and lung consolidation).
1 secondary outcome
Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery
Time frame: intraoperative
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 6 Jul 2016.
- Background: PubMed 20851923Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
- Background: PubMed 24662376Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
- Background: PubMed 10320601Serafini G, Cornara G, Cavalloro F, Mori A, Dore R, Marraro G, Braschi A. Pulmonary atelectasis during paediatric anaesthesia: CT scan evaluation and effect of positive endexpiratory pressure (PEEP). Paediatr Anaesth. 1999;9(3):225-8. doi: 10.1046/j.1460-9592.1999.00340.x.
- Background: PubMed 10325828Tusman G, Bohm SH, Vazquez de Anda GF, do Campo JL, Lachmann B. 'Alveolar recruitment strategy' improves arterial oxygenation during general anaesthesia. Br J Anaesth. 1999 Jan;82(1):8-13. doi: 10.1093/bja/82.1.8.
- Derived from this study: PubMed 29278555Acosta CM, Sara T, Carpinella M, Volpicelli G, Ricci L, Poliotto S, Abrego D, Gonorazky S, Bohm SH, Tusman G. Lung recruitment prevents collapse during laparoscopy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):573-580. doi: 10.1097/EJA.0000000000000761.
- Individual participant dataSharing planned: Undecided
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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.
Cecilia Maria Acosta, MD principal investigator
Hospital Privado de Comunidad
Questions about this trial
What is this clinical trial studying?
A study testing Lung recruitment maneuver in people with Atelectasis, run by Hospital Privado de Comunidad de Mar del Plata.
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 3 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score to assess the lung aeration (time frame: intraoperative). 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 NCT02824146, which also lists 5 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 6 Jul 2016.