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

NCT ID: NCT02824146

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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

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Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Recruitment maneuver group

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.

Group Type EXPERIMENTAL

Lung recruitment maneuver

Intervention Type 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.

Interventions

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Lung recruitment maneuver

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cecilia Maria Acosta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado de Comunidad

References

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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.

Reference Type BACKGROUND
PMID: 20851923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24662376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10320601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10325828 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29278555 (View on PubMed)

Other Identifiers

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Hospital Privado de Comunidad

Identifier Type: -

Identifier Source: org_study_id

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