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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Adolescence; Postoperative Atelectasis; Lung Recruitment
• Intervention / Treatment: Procedure: ultrasound- guided lung recruitment; Procedure: conventional lung recruitment

Detailed Description

In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragm 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 slight loss of aeration to complete atelectasis.

Scoliosis correction surgery for adolescent idiopathic scoliosis (AIS) is effective in preventing deterioration of lung function caused by disease progression, and improving lung volume over the long term. However, complications of the respiratory system and pulmonary dysfunction may occur in the immediate postoperative period. General anesthesia (GA) and positive pressure ventilation can cause decreased lung volumes, expiratory flow rates, and oxygenation after surgery as a result of positive pressure ventilation, partial recovery of respiratory muscle, pain, and immobilization.

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 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31111
      • Faculty of medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for elective correction of AIS
• aged between 10 and 25 years old
• American society of anesthesiologists (ASA) class I & II
• both genders

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional	Procedure: conventional lung recruitment; 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.
Active Comparator: ultrasound- guided	Procedure: ultrasound- guided lung recruitment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of atelectasis	the incidence of postoperative atelectasis in post-anaesthesia care unit	postoperative first 2 hours

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Pulmonary Atelectasis; Scoliosis
• Other Study ID Numbers: Atelectasis in scoliosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No