search
Back to results

Ultrasonographic Assessment of Lung Recruitment Maneuvers in Children Undergoing Lengthy Microsurgery Operations (RM)

Primary Purpose

Intraoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
RM 0.5
RM 0.3
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Complications

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 2-12 years old.
  • ASA physical status classification I-II.
  • Undergoing lengthy microsurgery operations
  • and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.-

Exclusion Criteria:

  • ASA Physical status classification >II.

    • Thoracic or abdominal surgery.
    • Preexisting lung disease.
    • Pre-operative chest infection or abnormal chest US findings.
    • Cardiac patients.-

Sites / Locations

  • Assiut university main hospital, Microsurgery unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.5. .

Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.3.

Outcomes

Primary Outcome Measures

Lung Areation Score
lung Areation Score calculated on first lung ultrasound.For a given thoracic area, points will be allocated to the worst LUS pattern observed and video clips of each region examined will be stored. The sum of the points obtained in all the 12 lung areas will define the LUS aeration score, ranging from 0 to 36 for the whole thorax. This score is inversely proportional to the degree of lung aeration.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2018
Last Updated
July 23, 2023
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03557905
Brief Title
Ultrasonographic Assessment of Lung Recruitment Maneuvers in Children Undergoing Lengthy Microsurgery Operations
Acronym
RM
Official Title
Ultrasonographic Assessment of Lung Recruitment Maneuvers in Pediatric Patients Undergoing Lengthy Microsurgery Operations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).
Detailed Description
To maximize the benefits, minimize the drawbacks and assess the adequacy of the recruitment maneuver; adequate monitoring at the bedside is essential. Several methods have been proposed, including measuring end-expiratory lung volume or pulmonary compliance, volumetric capnography, oxygenation indices, electrical impedance tomography, computerized tomography and lung ultrasound. For lung CT examination patients must be transported out to the radiation unit, which carries risk of transfer, high cost, and radiation exposure. The oxygenation method which is the most commonly used, but it is necessary to repeat arterial blood collection many times, which is cumbersome and expensive. Using lung ultrasound (LUS) as real-time guidance during the recruitment maneuver has gained popularity recently owing to its' easy applicability and non-invasive nature. Sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. Furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis in children. LUS can identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (PEEP) after RM and in the detection of the point of lung re-collapse after RM in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative FIO2 (0.5 VERSUS 0.3).
Masking
ParticipantOutcomes Assessor
Masking Description
Ventilator adjustments, lung recruitment, PEEP titration and ultrasonographic assessments will be done by well-trained investigators not involved in data collection. The surgeon, the parents or legal guardians and the data collection personell will be blinded to the patients' group assignment.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.5. .
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse at an FiO2 of 0.3.
Intervention Type
Device
Intervention Name(s)
RM 0.5
Other Intervention Name(s)
RM
Intervention Description
Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse.
Intervention Type
Device
Intervention Name(s)
RM 0.3
Other Intervention Name(s)
RM
Intervention Description
The patient will be ventilated with volume control mode with tidal volume 6 ml/kg, PEEP 3 cmH2O, an inspiratory expiratory ratio of 1:1.5, respiratory rate 20-25 breaths per minute depending on the patient's age and FiO2 of 0.3.
Primary Outcome Measure Information:
Title
Lung Areation Score
Description
lung Areation Score calculated on first lung ultrasound.For a given thoracic area, points will be allocated to the worst LUS pattern observed and video clips of each region examined will be stored. The sum of the points obtained in all the 12 lung areas will define the LUS aeration score, ranging from 0 to 36 for the whole thorax. This score is inversely proportional to the degree of lung aeration.
Time Frame
10 minutes after induction of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 2-12 years old. ASA physical status classification I-II. Undergoing lengthy microsurgery operations and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.- Exclusion Criteria: ASA Physical status classification >II. Thoracic or abdominal surgery. Preexisting lung disease. Pre-operative chest infection or abnormal chest US findings. Cardiac patients.-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdelghaffar, MD
Organizational Affiliation
Professor of anesthesia, faculty of medicine, Assiut university, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university main hospital, Microsurgery unit
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
715715
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasonographic Assessment of Lung Recruitment Maneuvers in Children Undergoing Lengthy Microsurgery Operations

We'll reach out to this number within 24 hrs