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Trial record 4 of 32 for:    Recruiting, Not yet recruiting, Available Studies | "Pulmonary Atelectasis"

Continuous Positive Airway Pressure Decreased Lung Collapse During General Anesthesia Induction in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03461770
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Privado de Comunidad de Mar del Plata

Brief Summary:

Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. Infants and young children are more susceptible to this lung collapse due to their small functional residual capacity. Thus, intrapulmonary shunting caused by those atelectasis are more likely to occur during general anesthesia in infants and younger children than in adults. This problem predisposes children to hypoxemic episodes that can persist in the early postoperative period. Beyond the negative impact of atelectasis on gas exchange, mechanical ventilation induces a local inflammatory response in atelectatic lungs, even in healthy patients undergoing general anesthesia.

Therefore, the diagnosis, prevention and active treatment of anesthesia-induced atelectasis are mandatory, not only to avoid hypoxemic episodes and atelectasis-related post-operative pulmonary complications, but also to protect the lungs during mechanical ventilation. Nowadays, the diagnosis of anesthesia-induced atelectasis is easily and accurately accomplished by lung ultrasound (LUS). LUS is a simple and non-invasive tool useful to detect atelectasis in children, to assess lung aeration and for monitoring ventilator settings or strategies. Regarding to the prevention of atelectasis, it was demonstrated that the application of continuous positive airway pressure (CPAP) during the induction of general anesthesia decreases atelectasis formation in adult morbidly obese patients.

The investigators hypothesized that the use of CPAP during general anesthesia induction in pediatric patients can prevent or decrease atelectasis formation.


Condition or disease Intervention/treatment Phase
Atelectasis Other: CPAP Not Applicable

Detailed Description:
Compare lung aeration between two different strategies of induction to general anesthesia: breathing throughout a facial mask without CPAP and breathing with 5 cmH20 of CPAP in pediatric patients scheduled for surgery under general anesthesia, using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure Decreased Lung Collapse During General Anesthesia Induction in Pediatric Patients
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Patients will receive anesthesia induction with Sevoflurane using a circular circuit without CPAP. Protective ventilation with 5 cmH20 of positive end-expiratory pressure (PEEP) will be initiated after induction. At the end of surgery, mechanical ventilation will stop allowing spontaneous ventilation. Patients will be extubated without CPAP. Lung ultrasound examinations will be performed at different times-points: before anesthesia induction, during surgery, at the end of surgery and before extubation, and after extubation.
Experimental: CPAP group
Patients will receive anesthesia induction using 5 cmH20 of CPAP until the moment of intubation. After induction patients will receive the same protective ventilation than the control group. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery. At the end of surgery, patients will be extubated under the modality of CPAP with 5 cmH20. Lung ultrasound examinations will be performed at different times-points: before anesthesia induction, during surgery, at the end of surgery and before extubation, and after extubation.
Other: CPAP
Patients will receive general anesthesia induction with CPAP at 5 cmH20 via face mask with a circular system. CPAP will use before extubation.The air-test will perform during anesthesia with transitory decreases inspired fraction of oxygen to 0.21 over a 5 min period. Recruitment maneuver will be perform if the air test is positive, ( SpO2 is ≤ 96%)




Primary Outcome Measures :
  1. Lung aeration during anesthesia [ Time Frame: intraoperative ]
    Compare lung aeration between two different strategies of induction to general anesthesia: breathing throughout a facial mask without CPAP and breathing with 5 cmH20 of CPAP in pediatric patients scheduled for surgery under general anesthesia, using ultrasound imaging and a four-point-aeration score to assess the lung aeration (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).


Secondary Outcome Measures :
  1. Peripheral arterial oxygenation by pulse oximetry [ Time Frame: intraoperative ]
    Peripheral capillary oxygen saturation (SpO2) by pulse oximetry will be recorded during intra-operative anesthesia with the 'Air-Test'.

  2. Lung aeration after surgery [ Time Frame: immediately after surgery ]
    Lung aeration score immediately after surgery, using ultrasound imaging and a four-point-aeration score to assess the lung aeration (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).



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Ages Eligible for Study:   6 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent by parents.
  • Patients aged 6 months to 7 years old
  • Scheduled for surgery under general anesthesia with tracheal intubation.
  • American Society of Anesthesiologists classification: physical status I-II

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461770


Contacts
Contact: Cecilia Acosta, MD +542234990074 ceciliamacosta@hotmail.com
Contact: Gerardo Tusman, MD +542234990074 gtusman@hotmail.com

Locations
Argentina
Cecilia M. Acosta Recruiting
Mar del Plata, Buenos Aires, Argentina, 7600
Sponsors and Collaborators
Hospital Privado de Comunidad de Mar del Plata
Investigators
Principal Investigator: Cecilia Acosta, MD Hospital Privado de Comunidad

Responsible Party: Hospital Privado de Comunidad de Mar del Plata
ClinicalTrials.gov Identifier: NCT03461770     History of Changes
Other Study ID Numbers: LUS IV
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Privado de Comunidad de Mar del Plata:
atelectasis
children
ultrasound

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs