Postoperative AtelectasisNCT05325463
Lung Recruitment Maneuvers for Postoperative Atelectasis Prevention After Idiopathic Adolescents' Scoliosis Correction
A study testing conventional lung recruitment and ultrasound- guided lung recruitment in people with Postoperative Atelectasis and Lung Recruitment, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Postoperative Atelectasis, Lung Recruitment, Scoliosis; Adolescence
- What is being tested?
- conventional lung recruitment and ultrasound- guided lung recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to 30 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients scheduled for elective correction of AIS
- aged between 10 and 25 years old
- American society of anesthesiologists (ASA) class I \& II
- both genders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- conventional lung recruitment, ultrasound- guided lung recruitment
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional lung recruitmentProcedure or surgery
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.
ultrasound- guided lung recruitmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| conventional | Experimental | Not described Receives: Procedure: conventional lung recruitment |
| ultrasound- guided | Active comparator | Not described Receives: Procedure: ultrasound- guided lung recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of atelectasis
the incidence of postoperative atelectasis in post-anaesthesia care unit
Measured: postoperative first 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start10 Apr 2022
- Primary completion1 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325463
- Sponsor's protocol ID
- Atelectasis in scoliosis
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No