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Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis

Primary Purpose

Atelectasis, Postoperative Complications, Recruitment

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional recruitment maneuvers
ultrasound-guided recruitment maneuvers
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients scheduled for laparoscopic abdominal surgery American Society of anaesthesiologist class I & II Exclusion Criteria: Pre-existing cardiac disease. Morbidly obese patients according to age. Patients with previous thoracic or cardiac surgery. Upper or lower airway infection within 2 weeks before the surgery. Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion. Abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia. Preoperative oxygen saturation measured by pulse oximetry (SpO2) of 96% or less on room air.

Sites / Locations

  • Faculty of medicine, Tanta universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional

ultrasound-guided

Arm Description

Outcomes

Primary Outcome Measures

The incidence of atelectasis
The incidence of atelectasis in post anesthesia care unit

Secondary Outcome Measures

Full Information

First Posted
March 8, 2023
Last Updated
March 8, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05777018
Brief Title
Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis
Official Title
Safety and Efficacy of Ultrasound Guided Lung Recruitment Maneuvers for Prevention of Postoperative Atelectasis After Pediatric Laparoscopic Abdominal Surgery: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta 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
In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung aeration. The mass of the abdominal organs pushes the diaphragm cranially compressing the lungs in the most dependent areas. Such regional lung collapse may range from a slight loss of aeration to complete atelectasis.
Detailed Description
A wide variety of recruitment maneuvers has been described. The most relevant are represented by sustained inflation maneuvers, high pressure-controlled ventilation, incremental PEEP, and intermittent sighs. However, the best recruitment maneuver technique is currently unknown and may vary according to the specific circumstances. The most commonly used recruitment maneuver is the sustained inflation technique, in which a continuous pressure of 40 cm H2O is applied to the airways for up to 60 seconds. Sustained inflation has been shown to be effective in reducing lung atelectasis, improving oxygenation and respiratory mechanics, and preventing endotracheal suctioning-induced alveolar derecruitment. However, the efficacy of sustained inflation has been questioned and other studies showed that this intervention may be ineffective, short-lived, or associated with circulatory impairment, an increased risk of baro/volutrauma, a reduced net alveolar fluid clearance, or even worsened oxygenation. Lung ultrasound has been gaining consensus as a noninvasive, radiation-free tool for diagnosing various pulmonary diseases in adult and pediatric patients. Evidence supporting lung ultrasound use is expanding beyond emergency and critical care settings to perioperative care. It has been reported that lung ultrasound (LUS) at a patient's bedside immediately following surgery can be useful for diagnosing respiratory complications. LUS has been proven to be a valuable bedside diagnostic tool for pneumothorax, with high sensitivity and specificity (78.6% and 98.4%, respectively), and a higher rate of detecting abnormalities such as lung alveolar consolidation and pleural effusion than bedside chest X-ray or physical examination. LUS has also been used to diagnose anesthesia-induced atelectasis in pediatric patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative Complications, Recruitment, Pediatric, Abdominal Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional
Arm Type
Active Comparator
Arm Title
ultrasound-guided
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
conventional recruitment maneuvers
Other Intervention Name(s)
control
Intervention Description
The recruitment maneuver will be performed at 3 predefined time points: 5 minutes after induction of GA (T2), 5 minutes after insufflation of the capnoperitoneum (T3), After the end of surgery and before recovery from anesthesia (T4). by pressure controlled mode starting with an airway pressure of 15 cmH2O the subsquently changed ( decrease or increase) to provide targeted tidal volume according to each patient, maintaining end-tidal carbon dioxide between 35 to 45 mmHg with 5 cmH2O increments in PEEP until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 s. The peak airway pressure will be maintained for 10 s or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided recruitment maneuvers
Intervention Description
Ultrasound guided maneuver will be performed at T2, T3 and T4. The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area is visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit will be 40 cmH2O. The Recruitment maneuvers (RM) will be started searching the pressure level at which the consolidation pattern disappears and progressive lung re-aeration is observed and will be recorded for all patients (the lung's opening pressure).(14) Lung ultrasound examination will be performed every 5 cmH2O increments in PEEP to detect the lung's opening pressure.
Primary Outcome Measure Information:
Title
The incidence of atelectasis
Description
The incidence of atelectasis in post anesthesia care unit
Time Frame
postoperative first 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for laparoscopic abdominal surgery American Society of anaesthesiologist class I & II Exclusion Criteria: Pre-existing cardiac disease. Morbidly obese patients according to age. Patients with previous thoracic or cardiac surgery. Upper or lower airway infection within 2 weeks before the surgery. Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion. Abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia. Preoperative oxygen saturation measured by pulse oximetry (SpO2) of 96% or less on room air.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tarek A Mostafa, MD
Phone
+20403288260
Email
dr.tarek311@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hoda ezz
Organizational Affiliation
tanta university, faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Tanta university
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tarek Mostafa
Phone
020403332033
Email
dr.tarek311@yahoo.com
First Name & Middle Initial & Last Name & Degree
sameh Ahmed
Email
samehabdelkhalik1982@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis

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