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Completed

NCT Number: NCT03745443

Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

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.

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Key information

Conditions

Healthy

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Mother and Child Health Care dr Vukan Cupic

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

increase and decrease positive end-expiratory pressure

Procedure

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 names: ventilation with PEEP 3

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mother and Child Health Institute of Serbia Dr Vukan Cupic

Other

Registry information

Official study title

The Assessment of Efficacy and Safety of Step-wise up and Down PEEP Titration in Healthy Pediatric Patients Under General Anesthesia

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 19, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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