Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery
Primary Purpose
Atelectasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung recruitment maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Atelectasis focused on measuring atelectasis, children, lung ultrasound, lung recruitment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Acute airway infection
- Cardiovascular and or pulmonary disease
- Previous thoracic procedure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Recruitment maneuver group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery
Full Information
NCT ID
NCT02824146
First Posted
June 23, 2016
Last Updated
July 1, 2016
Sponsor
Hospital Privado de Comunidad de Mar del Plata
1. Study Identification
Unique Protocol Identification Number
NCT02824146
Brief Title
Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery
Official Title
Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Abdominal Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Privado de Comunidad de Mar del Plata
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
atelectasis, children, lung ultrasound, lung recruitment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Recruitment maneuver group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lung recruitment maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Acute airway infection
Cardiovascular and or pulmonary disease
Previous thoracic procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Maria Acosta, MD
Organizational Affiliation
Hospital Privado de Comunidad
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20851923
Citation
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.
Results Reference
background
PubMed Identifier
24662376
Citation
Acosta 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.
Results Reference
background
PubMed Identifier
10320601
Citation
Serafini 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.
Results Reference
background
PubMed Identifier
10325828
Citation
Tusman 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.
Results Reference
background
PubMed Identifier
29278555
Citation
Acosta 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.
Results Reference
derived
Learn more about this trial
Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery
We'll reach out to this number within 24 hrs