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Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03745443
Enrollment
70
Registered
2018-11-19
Start date
2017-01-20
Completion date
2017-06-25
Last updated
2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

PROCEDUREincrease 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

Sponsors

Mother and Child Health Institute of Serbia Dr Vukan Cupic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

randomized parallel controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Partial pressure of oxygen10 minutes after PEEP titrationmeasured partial pressure of oxygen in arterial blood at the end of surgery in Interventional and Control group.
Partial pressure of carbon dioxide10 minutes after PEEP titrationmeasured partial pressure carbon dioxide in arterial blood at the end of surgery in Interventional and in Control group
Lung compliance10 minutes after PEEP titrationspirometric measurement of dynamic lung compliance at the end of surgery in Interventional and Control group

Secondary

MeasureTime frameDescription
postoperative hemoglobin oxygen saturation4 hours after extubationhemoglobin oxygen saturation measured with puls oximeter
intraoperative hemodynamic status5 minutesinvasive blood pressure monitoring during PEEP titration in Interventional group
intraoperative respiratory adverse effect5 minutesairway pressure monitoring during PEEP titration in Interventional group

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026