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Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

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ClinicalTrials.gov Identifier: NCT03745443
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Mandras, Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"

Brief Summary:
During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs intraoperatively. Positive end-expiratory pressure (PEEP) is distending pressure that prevents alveolar collapse during mechanical ventilation and is a part of recruitment maneuver that is often used in patients on mechanical ventilation. Overall effect of PEEP is improvement in lung function. PEEP can have adverse effects on hemodynamics. The objective of this study was to assess the effect of step up and down PEEP titration on lung function and hemodynamics in healthy preschool children during general anesthesia. One group of children was ventilated with constant PEEP. the other was submitted to PEEP titration. Changes in lung compliance, gas exchange and hemodynamic status were documented as well as any unwanted effects.

Condition or disease Intervention/treatment Phase
Healthy Procedure: increase and decrease positive end-expiratory pressure Not Applicable

Detailed Description:
Seventy preschool children American Society of Anesthesiologists classification system (ASA) I and II scheduled for non-cardiothoracic surgery were allocated in two groups. Interventional group (n=35) received PEEP titration and Control group (n=35) didn't. They were ventilated only with PEEP 3. PEEP titration: In Intervention group, 20 minutes before the end of anesthesia PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then PEEP was reduced by 2 on every 5 breaths to 5 and remain as until awakening. Total time to perform titration was 5 minutes. Blood was collected in both groups, in equal points of time that is: after induction, 20 minutes before the end of surgery and after the end of surgery (20th minute). Investigators tested differences of outcome variables between groups and within the Interventional group before and after PEEP titration. Hemodynamic monitoring and monitoring of lung function were conducted in Interventional group to observe changes during PEEP titration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized parallel controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Assessment of Efficacy and Safety of Step-wise up and Down PEEP Titration in Healthy Pediatric Patients Under General Anesthesia
Actual Study Start Date : January 20, 2017
Actual Primary Completion Date : June 25, 2017
Actual Study Completion Date : June 25, 2017

Arm Intervention/treatment
Experimental: Intervention group
Intervention: increase and decrease positive end-expiratory pressure. PEEP titration: 20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11 ventilation was maintained on PEEP 11 for 2 minutes.Then, PEEP was reduced by 2 for every 5 breaths to 5.Total time to titrate was 5 minutes.
Procedure: increase and decrease positive end-expiratory pressure
20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then, PEEP was reduced by 2 on every 5 breaths to 5 cmH2O
Other Name: ventilation with PEEP 3

No Intervention: Control
Ventilation with PEEP 3 during anesthesia and surgery



Primary Outcome Measures :
  1. Partial pressure of oxygen [ Time Frame: 10 minutes after PEEP titration ]
    measured partial pressure of oxygen in arterial blood at the end of surgery in Interventional and Control group.

  2. Partial pressure of carbon dioxide [ Time Frame: 10 minutes after PEEP titration ]
    measured partial pressure carbon dioxide in arterial blood at the end of surgery in Interventional and in Control group

  3. Lung compliance [ Time Frame: 10 minutes after PEEP titration ]
    spirometric measurement of dynamic lung compliance at the end of surgery in Interventional and Control group

  4. Lung compliance [ Time Frame: 5 minutes ]
    spirometric measurement of dynamic lung compliance on different PEEP levels in Interventional group


Secondary Outcome Measures :
  1. postoperative hemoglobin oxygen saturation [ Time Frame: 4 hours after extubation ]
    hemoglobin oxygen saturation measured with puls oximeter

  2. intraoperative hemodynamic status [ Time Frame: 5 minutes ]
    invasive blood pressure monitoring during PEEP titration in Interventional group

  3. intraoperative respiratory adverse effect [ Time Frame: 5 minutes ]
    airway pressure monitoring during PEEP titration in Interventional group



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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 3-7; ASA I and II
  • absence of cardiovascular and respiratory comorbidity

Exclusion criteria:

  • current or recent (up to 4 weeks) upper airway infection
  • present of gastroesophageal reflux
  • allergic reactions to anesthetics
  • contraindication to chosen anesthetics

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): NCT03745443


Locations
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Serbia
Institute for Mother and Child Health Care dr Vukan Cupic
Belgrade, Serbia, 11000
Sponsors and Collaborators
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
Investigators
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Principal Investigator: Ana Mandras, MD Institute for Mother and Child Health Care

Publications of Results:
Other Publications:
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Responsible Party: Ana Mandras, Principal Investigator Anesthesiologist, Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
ClinicalTrials.gov Identifier: NCT03745443     History of Changes
Other Study ID Numbers: 8/30,2017
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs