Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

NCT03745443 | Completed DMC

• 1 other identifier: 8/30,2017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• postoperative hemoglobin oxygen saturation

  4 hours after extubation

• intraoperative hemodynamic status

  5 minutes

• intraoperative respiratory adverse effect

  5 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control

NO INTERVENTION

Ventilation with PEEP 3 during anesthesia and surgery

Interventions

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

Also known as: ventilation with PEEP 3

Intervention group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 3-7; ASA I and II
• absence of cardiovascular and respiratory comorbidity

You may not qualify if:

• current or recent (up to 4 weeks) upper airway infection
• present of gastroesophageal reflux
• allergic reactions to anesthetics
• contraindication to chosen anesthetics

Sponsors & Collaborators

• Mother and Child Health Institute of Serbia Dr Vukan Cupic: lead

Study Sites (1)

Institute for Mother and Child Health Care dr Vukan Cupic

Belgrade, 11000, Serbia

Location

Related Publications (4)

• 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.

  PMID: 26228052 BACKGROUND

• 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.

  PMID: 21057351 BACKGROUND

• 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.

  PMID: 30355345 BACKGROUND

• 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.

  PMID: 12974591 RESULT

MeSH Terms

Interventions

Ventilation

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Ana Mandras, MD

  Institute for Mother and Child Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Anesthesiologist

Model Details: randomized parallel controlled clinical trial

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: January 20, 2017
• Primary Completion: June 25, 2017
• Study Completion: June 25, 2017
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)