Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

NCT ID: NCT03745443

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2017-06-25

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

increase and decrease positive end-expiratory pressure

Intervention Type: 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

Control

Ventilation with PEEP 3 during anesthesia and surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

ventilation with PEEP 3

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mother and Child Health Institute of Serbia Dr Vukan Cupic

OTHER

Sponsor Role: lead

Responsible Party

Ana Mandras

Principal Investigator Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Mandras, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Mother and Child Health Care

Locations

Institute for Mother and Child Health Care dr Vukan Cupic

Belgrade, , Serbia

Countries

Serbia

References

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.

Reference Type: BACKGROUND

PMID: 26228052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21057351 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30355345 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12974591 (View on PubMed)

Other Identifiers

8/30,2017

Identifier Type: -

Identifier Source: org_study_id