Clinical trial NCT03745443: Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia
Official title: The Assessment of Efficacy and Safety of Step-wise up and Down PEEP Titration in Healthy Pediatric Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Mother and Child Health Institute of Serbia Dr Vukan Cupic
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized parallel controlled clinical trial
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Partial pressure of oxygen
timeFrame: 10 minutes after PEEP titration
measure: Partial pressure of carbon dioxide
timeFrame: 10 minutes after PEEP titration
measure: Lung compliance
timeFrame: 10 minutes after PEEP titration
measure: Lung compliance
timeFrame: 5 minutes
Secondary outcomes:
measure: postoperative hemoglobin oxygen saturation
timeFrame: 4 hours after extubation
measure: intraoperative hemodynamic status
timeFrame: 5 minutes
measure: intraoperative respiratory adverse effect
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Institute for Mother and Child Health Care dr Vukan Cupic
Study officials:
affiliation: Institute for Mother and Child Health Care
name: Ana Mandras, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doras C, Le Guen M, Petak F, Habre W. Cardiorespiratory effects of recruitment maneuvers and positive end expiratory pressure in an experimental context of acute lung injury and pulmonary hypertension. BMC Pulm Med. 2015 Jul 31;15:82. doi: 10.1186/s12890-015-0079-y.
citation: Boriosi JP, Sapru A, Hanson JH, Asselin J, Gildengorin G, Newman V, Sabato K, Flori HR. Efficacy and safety of lung recruitment in pediatric patients with acute lung injury. Pediatr Crit Care Med. 2011 Jul;12(4):431-6. doi: 10.1097/PCC.0b013e3181fe329d.
citation: Cruces P, Gonzalez-Dambrauskas S, Cristiani F, Martinez J, Henderson R, Erranz B, Diaz F. Positive end-expiratory pressure improves elastic working pressure in anesthetized children. BMC Anesthesiol. 2018 Oct 24;18(1):151. doi: 10.1186/s12871-018-0611-8.
citation: Mascotto G, Bizzarri M, Messina M, Cerchierini E, Torri G, Carozzo A, Casati A. Prospective, randomized, controlled evaluation of the preventive effects of positive end-expiratory pressure on patient oxygenation during one-lung ventilation. Eur J Anaesthesiol. 2003 Sep;20(9):704-10. doi: 10.1017/s0265021503001145.