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
- Are there results?
- None posted in the registry
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05325463
- Acronym / sponsor ID
- Atelectasis in scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Experimental | Procedure: conventional lung recruitment |
| ultrasound- guided | Active comparator | Procedure: ultrasound- guided lung recruitment |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective correction of AIS
- aged between 10 and 25 years old
- American society of anesthesiologists (ASA) class I \& II
- both genders
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional lung recruitmentThe 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. | Procedure or surgery | conventional |
| ultrasound- guided lung recruitmentThe 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. | Procedure or surgery | ultrasound- guided |
Primary outcome
the incidence of atelectasis
Time frame: postoperative first 2 hours
the incidence of postoperative atelectasis in post-anaesthesia care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of atelectasis (time frame: postoperative first 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.