Lung Recruitment Maneuvers for Postoperative Atelectasis Prevention After Idiopathic Adolescents' Scoliosis Correction
Safety and Efficacy of Ultrasound-guided Lung Recruitment Maneuvers for Prevention of Postoperative Atelectasis After Surgical Correction of Idiopathic Adolescent Scoliosis. A Prospective Randomized Study
1 other identifier
interventional
90
1 country
1
Brief Summary
The investigators hypothesized that an ultrasound-guided lung recruitment maneuvers would be more effective in preventing postoperative atelectasis than conventional alveolar recruitment after surgical correction of idiopathic adolescent scoliosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2022
CompletedStudy Start
First participant enrolled
April 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMay 1, 2024
April 1, 2024
2 years
April 6, 2022
April 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
the incidence of atelectasis
the incidence of postoperative atelectasis in post-anaesthesia care unit
postoperative first 2 hours
Study Arms (2)
conventional
EXPERIMENTALultrasound- guided
ACTIVE COMPARATORInterventions
The recruitment maneuver will be performed by pressure controlled mode maintaining a steady airway pressure of 15 cmH2O, with 5 cmH2O increments in positive end-expiratory pressure (PEEP) until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 sec. The peak airway pressure will be maintained for 10 sec or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings.
The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area was visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit was 40 cmH2O.
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective correction of AIS
- aged between 10 and 25 years old
- American society of anesthesiologists (ASA) class I \& II
- both genders
You may not qualify if:
- Morbidly obese patients
- patients with previous thoracic surgery
- upper or lower airway infection within 2 weeks before the surgery
- abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of medicine, Tanta university
Tanta, El Gharbyia, 31111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
April 6, 2022
First Posted
April 13, 2022
Study Start
April 10, 2022
Primary Completion
April 1, 2024
Study Completion
April 30, 2024
Last Updated
May 1, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share