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

NCT03557905 | Completed DMC

• 1 other identifier: 17200202
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Intraoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes after induction of anesthesia

Study Arms (2)

Group I

ACTIVE COMPARATOR

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. .

Device: RM 0.5

Group II

ACTIVE COMPARATOR

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.

Device: RM 0.3

Interventions

RM 0.5 DEVICE

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

Also known as: RM

Group I

RM 0.3 DEVICE

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.

Also known as: RM

Group II

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.-

You may not qualify if:

• ASA Physical status classification \>II.
• Thoracic or abdominal surgery.
• Preexisting lung disease.
• Pre-operative chest infection or abnormal chest US findings.
• Cardiac patients.-

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital, Microsurgery unit

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala S Abdelghaffar, MD

  Professor of anesthesia, faculty of medicine, Assiut university, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Model Details: 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).

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: August 6, 2018
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)