Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery

NCT02824146 | Completed DMC

• 1 other identifier: Hospital Privado de Comunidad
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atelectasis

Keywords

atelectasis; children; lung ultrasound; lung recruitment

Outcome Measures

Primary Outcomes (1)

• 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).

  intraoperative

Secondary Outcomes (1)

• Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery

  intraoperative

Study Arms (2)

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.

Other: Lung recruitment maneuver

Interventions

Lung recruitment maneuver OTHER

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.

Recruitment maneuver group

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Acute airway infection
• Cardiovascular and or pulmonary disease
• Previous thoracic procedure

Sponsors & Collaborators

• Hospital Privado de Comunidad de Mar del Plata: lead

Related Publications (5)

• 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.

  PMID: 20851923 BACKGROUND

• 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.

  PMID: 24662376 BACKGROUND

• 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.

  PMID: 10320601 BACKGROUND

• 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.

  PMID: 10325828 BACKGROUND

• 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.

  PMID: 29278555 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cecilia Maria Acosta, MD

  Hospital Privado de Comunidad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 6, 2016
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-06