Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound

NCT03069157 | Completed

• 1 other identifier: N-33-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients 5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask. The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced atelectasis using intraoperative lung ultrasound. Objectives

• To determine the effect of recruitment on anesthesia induced atelectasis using lung ultrasound.
• To Estimate the change of Pao2 with anesthesia induced lung atelectasis.
• To Estimate the change of Pao2 with lung recruitment.
• To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung recruitment.

Conditions

Anesthesia Induced Atelectasis

Outcome Measures

Primary Outcomes (1)

• The lung aeration score 5minutes following induction of general anesthesia

  Atelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0

  Lung ultrasound examinations will be performed 5minutes following induction of general anesthesia

Secondary Outcomes (1)

• •The sum of surface area of atelectatic regions

  It will be measured at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia,5 min before extubation and 5 min after extubation at recovery room to detect and monitor atelectasis

Study Arms (2)

Without lung recruitment maneuver

NO INTERVENTION

patient ventilation will be maintained After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5 without recruitment but with PEEP 5cm H2O.

recruitment group

ACTIVE COMPARATOR

lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O.

Procedure: lung recruitment maneuver

Interventions

lung recruitment maneuver PROCEDURE

lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O

recruitment group

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I-II.
• Age (1-4) years.
• Patients undergoing major abdominal surgery in supine position (eg. Splenectomy, exploration, kasai etc.,).

You may not qualify if:

• Parents' refusal.
• Patients with congenital heart disease.
• Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,)
• Patients with respiratory tract infection.
• Patients with chest wall deformities

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• Cairo University: collaborator

Study Sites (1)

Kasr Alainy, Cairo University

Cairo, 202, Egypt

Location

Study Officials

• Iman R Abdel- Aal, Professor

  Anesthesia department , Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by computer generated numbers and concealed by serially numbered,opague and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Anesthesia and surgical icu, Principal Investigator, Assistant lecturer

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 3, 2017
• Study Start: March 8, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)