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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: increase and decrease positive end-expiratory pressure

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Mother and Child Health Care dr Vukan Cupic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: ventilation with PEEP 3
No Intervention: Control; Ventilation with PEEP 3 during anesthesia and surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
• Investigators: Principal Investigator: Ana Mandras, MD, Institute for Mother and Child Health Care

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Actual): June 25, 2017
• Study Completion (Actual): June 25, 2017

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 8/30,2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No