Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745443
• Other study ID #: 8/30,2017
• Status: Completed
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: June 25, 2017

Study information

• Verified date: November 2018
• Source: Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 25, 2017
• Est. primary completion date: June 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Serbia	Institute for Mother and Child Health Care dr Vukan Cupic	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"

Country where clinical trial is conducted

Serbia, 

References & Publications (4)

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. — View Citation

Cruces P, González-Dambrauskas S, Cristiani F, Martínez J, Henderson R, Erranz B, Díaz 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. — View Citation

Doras C, Le Guen M, Peták 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. — View 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 Anaesthe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Lung compliance	spirometric measurement of dynamic lung compliance at the end of surgery in Interventional and Control group	10 minutes after PEEP titration
Primary	Lung compliance	spirometric measurement of dynamic lung compliance on different PEEP levels in Interventional group	5 minutes
Secondary	postoperative hemoglobin oxygen saturation	hemoglobin oxygen saturation measured with puls oximeter	4 hours after extubation
Secondary	intraoperative hemodynamic status	invasive blood pressure monitoring during PEEP titration in Interventional group	5 minutes
Secondary	intraoperative respiratory adverse effect	airway pressure monitoring during PEEP titration in Interventional group	5 minutes