Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: increase and decrease positive end-expiratory pressure

• Registration Number: NCT03745443
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-01-20
• Primary Completion: 2017-06-25
• Study Completion: 2017-06-25
• Status Verified: 2018-11
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	increase and decrease positive end-expiratory pressure	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.

Primary Outcome Measures

Name	Time	Method
Partial pressure of oxygen	10 minutes after PEEP titration	measured partial pressure of oxygen in arterial blood at the end of surgery in Interventional and Control group.
Partial pressure of carbon dioxide	10 minutes after PEEP titration	measured partial pressure carbon dioxide in arterial blood at the end of surgery in Interventional and in Control group
Lung compliance	5 minutes	spirometric measurement of dynamic lung compliance on different PEEP levels in Interventional group

Secondary Outcome Measures

Name	Time	Method
intraoperative respiratory adverse effect	5 minutes	airway pressure monitoring during PEEP titration in Interventional group
intraoperative hemodynamic status	5 minutes	invasive blood pressure monitoring during PEEP titration in Interventional group
postoperative hemoglobin oxygen saturation	4 hours after extubation	hemoglobin oxygen saturation measured with puls oximeter

Trial Locations

Locations (1)

Institute for Mother and Child Health Care dr Vukan Cupic; 🇷🇸 Belgrade, Serbia