AtelectasisNCT05777018
Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis
A study testing conventional recruitment maneuvers and ultrasound-guided recruitment maneuvers in people with Atelectasis and Postoperative Complications, run by Tanta University at 1 site in Egypt.
Trial summary
In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung aeration. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Atelectasis, Postoperative Complications, Recruitment
- What is being tested?
- conventional recruitment maneuvers and ultrasound-guided recruitment maneuvers
- 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
- 1 Dec 2022to 30 Aug 2023
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients scheduled for laparoscopic abdominal surgery
- American Society of anaesthesiologist class I \& II
Who cannot join
- Pre-existing cardiac disease.
- Morbidly obese patients according to age.
- Patients with previous thoracic or cardiac surgery.
- Upper or lower airway infection within 2 weeks before the surgery.
- Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion.
- Abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia.
- Preoperative oxygen saturation measured by pulse oximetry (SpO2) of 96% or less on room air.
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 Pediatric Laparoscopic Abdominal Surgery: A Prospective Randomized Study
In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic 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 a slight loss of aeration to complete atelectasis.
Read the detailed description
A wide variety of recruitment maneuvers has been described. The most relevant are represented by sustained inflation maneuvers, high pressure-controlled ventilation, incremental PEEP, and intermittent sighs. However, the best recruitment maneuver technique is currently unknown and may vary according to the specific circumstances. The most commonly used recruitment maneuver is the sustained inflation technique, in which a continuous pressure of 40 cm H2O is applied to the airways for up to 60 seconds. Sustained inflation has been shown to be effective in reducing lung atelectasis, improving oxygenation and respiratory mechanics, and preventing endotracheal suctioning-induced alveolar derecruitment. However, the efficacy of sustained inflation has been questioned and other studies showed that this intervention may be ineffective, short-lived, or associated with circulatory impairment, an increased risk of baro/volutrauma, a reduced net alveolar fluid clearance, or even worsened oxygenation.
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 been 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 recruitment maneuvers, ultrasound-guided recruitment maneuvers
- Medical subject headings
- Pulmonary Atelectasis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional recruitment maneuversProcedure or surgery
Also called control
The recruitment maneuver will be performed at 3 predefined time points: 5 minutes after induction of GA (T2), 5 minutes after insufflation of the capnoperitoneum (T3), After the end of surgery and before recovery from anesthesia (T4).
by pressure controlled mode starting with an airway pressure of 15 cmH2O the subsquently changed ( decrease or increase) to provide targeted tidal volume according to each patient, maintaining end-tidal carbon dioxide between 35 to 45 mmHg with 5 cmH2O increments in PEEP until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 s. The peak airway pressure will be maintained for 10 s or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings
ultrasound-guided recruitment maneuversProcedure or surgery
- Ultrasound guided maneuver will be performed at T2, T3 and T4.
- The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area is visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit will be 40 cmH2O. The Recruitment maneuvers (RM) will be started searching the pressure level at which the consolidation pattern disappears and progressive lung re-aeration is observed and will be recorded for all patients (the lung's opening pressure).(14) Lung ultrasound examination will be performed every 5 cmH2O increments in PEEP to detect the lung's opening pressure.
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | Not described Receives: Procedure: conventional recruitment maneuvers |
| ultrasound-guided | Active comparator | Not described Receives: Procedure: ultrasound-guided recruitment maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of atelectasis
The incidence of atelectasis in post anesthesia 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 posted20 Mar 2023
- Study start1 Dec 2022
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- Investigators
- hoda ezz, Principal investigator, tanta university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777018
- Sponsor's protocol ID
- atelectasis in pediatrics
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2023
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. 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 Pediatric Laparoscopic Abdominal Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05777018
- Acronym / sponsor ID
- atelectasis in pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 20 Mar 2023 (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.
In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic 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 a slight loss of aeration to complete atelectasis.
Detailed description
A wide variety of recruitment maneuvers has been described. The most relevant are represented by sustained inflation maneuvers, high pressure-controlled ventilation, incremental PEEP, and intermittent sighs. However, the best recruitment maneuver technique is currently unknown and may vary according to the specific circumstances. The most commonly used recruitment maneuver is the sustained inflation technique, in which a continuous pressure of 40 cm H2O is applied to the airways for up to 60 seconds. Sustained inflation has been shown to be effective in reducing lung atelectasis, improving oxygenation and respiratory mechanics, and preventing endotracheal suctioning-induced alveolar derecruitment. However, the efficacy of sustained inflation has been questioned and other studies showed that this intervention may be ineffective, short-lived, or associated with circulatory impairment, an increased risk of baro/volutrauma, a reduced net alveolar fluid clearance, or even worsened oxygenation.
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 been 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Procedure: conventional recruitment maneuvers |
| ultrasound-guided | Active comparator | Procedure: ultrasound-guided recruitment maneuvers |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients scheduled for laparoscopic abdominal surgery
- American Society of anaesthesiologist class I \& II
Key exclusion criteria (7 listed)
- Pre-existing cardiac disease.
- Morbidly obese patients according to age.
- Patients with previous thoracic or cardiac surgery.
- Upper or lower airway infection within 2 weeks before the surgery.
- Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion.
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 recruitment maneuversAlso: controlThe recruitment maneuver will be performed at 3 predefined time points: 5 minutes after induction of GA (T2), 5 minutes after insufflation of the capnoperitoneum (T3), After the end of surgery and before recovery from anesthesia (T4). by pressure controlled mode starting with an airway pressure of 15 cmH2O the subsquently changed ( decrease or increase) to provide targeted tidal volume according to each patient, maintaining end-tidal carbon dioxide between 35 to 45 mmHg with 5 cmH2O increments in PEEP until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 s. The peak airway pressure will be maintained for 10 s or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings | Procedure or surgery | conventional |
| ultrasound-guided recruitment maneuvers* Ultrasound guided maneuver will be performed at T2, T3 and T4. * The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area is visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit will be 40 cmH2O. The Recruitment maneuvers (RM) will be started searching the pressure level at which the consolidation pattern disappears and progressive lung re-aeration is observed and will be recorded for all patients (the lung's opening pressure).(14) Lung ultrasound examination will be performed every 5 cmH2O increments in PEEP to detect the lung's opening pressure. | Procedure or surgery | ultrasound-guided |
Primary outcome
The incidence of atelectasis
Time frame: postoperative first 2 hours
The incidence of atelectasis in post anesthesia 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 22 Nov 2023.
- 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.
hoda ezz principal investigator
tanta university, faculty of medicine
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 recruitment maneuvers and ultrasound-guided recruitment maneuvers in people with Atelectasis and Postoperative Complications, 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 2 inclusion and 7 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 22 Nov 2023. 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 22 Nov 2023.