Ultrasound Guided Recruitment ManauvereNCT06306820
Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery
A study testing Fixed PEEP, Ultrasound-guided lung recruitment and Individualized PEEP in people with Ultrasound Guided Recruitment Manauvere and End Expiratory Pressure, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Ultrasound Guided Recruitment Manauvere, End Expiratory Pressure, Pediatric Patients
- What is being tested?
- Fixed PEEP, Ultrasound-guided lung recruitment and Individualized PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2024to 1 Aug 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 3 to 8 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Children scheduled for elective laparoscopic abdominal surgeries.
Who cannot join
- Parental refusal.
- Bronchial asthma or any preexisting chest disease.
- Congenital deformity of the thoracic cage.
- Patients with a history of thoracic surgery.
- Cardiac, hepatic, or renal failure.
- Obese children with BMI at or above 95th percentile of the same age and sex.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Reham M Rezk, MBBCH, 00201013193723, rehamrezk95@gmail.com
Soher M Soliman, MD
About this study
Official title: Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery; A Prospective Randomized Controlled Study.
The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.
Read the detailed description
Atelectasis is among the most frequent postoperative pulmonary complications (PPCs) of general anesthesia with an incidence of between 68% and 100% in children. Atelectasis impairs gas exchange, thus causing hypoxemia and other respiratory disorders such as acute lung injury and pneumonia.
Pneumoperitoneum is another risk factor for perioperative atelectasis. It elevates the diaphragm and intra-abdominal pressure. In order to prevent atelectasis, applying positive end-expiratory pressure (PEEP) or an alveolar recruitment Maneuvere (RM) have shown beneficial effects.
Lung ultrasound (US) is a noninvasive, radiation-free, convenient, and reproducible bedside imaging modality for anesthesia-induced atelectasis in children.
- Conditions
- Ultrasound Guided Recruitment Manauvere, End Expiratory Pressure, Pediatric Patients, Laparoscopic Abdominal Surgery
- Being tested
- Fixed PEEP, Ultrasound-guided lung recruitment, Individualized PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed PEEPOther
Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O throughout the surgical procedure.
Ultrasound-guided lung recruitmentOther
Patients will receive ultrasound-guided lung before pneumoperitoneum, after pneumoperitoneum then once an hour, until the end of surgery. Alveolar recruitment will be conducted the same as that for the conventional manoeuvre with a simultaneous continuous ultrasound assessment if atalectasis is detected until no collapsed areas are visualized. When the collapsed lung areas are absent on the sonogram, positive end-expiratory pressure (PEEP) can no longer increase at this point. Subsequently, the pressure will be maintained for approximately 10 breaths.
Individualized PEEPOther
Patients will receive individualized positive end-expiratory pressure (PEEP). After the first recruitment Maneuvere (RM), titration of PEEP will be performed by setting the initial PEEP to 5 cm H2O, then increasing PEEP according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: [Cstat = VT/Pplat - PEEP] (Pplat = plateau pressure), then gradually increasing PEEP, until the calculated Cstat shows a downward trend, the we set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEP for this patient. The highest PEEP is limited to 15 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O. Receives: Other: Fixed PEEP |
| Ultrasound group | Experimental | Patients will receive ultrasound -guided lung recruitment. Receives: Other: Ultrasound-guided lung recruitment |
| PEEP IND group | Experimental | Patients will receive individualized positive end-expiratory pressure (PEEP). Receives: Other: Individualized PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative oxygenation
Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen P/F ratio will be assessed before induction of anesthesia, one hour after pneumoperitoneum, and after second recruitment Maneuvere (RM)
Measured: One hour after second recruitment Maneuvere
Secondary outcomes (4)
Lung ultrasound scores
Lung ultrasound scores to assess anesthesia-induced atelectasis and will be performed immediately after intubation, one hour after pneumoperitoneum, one hour after extubation, and 24 hours after extubation
Measured: 24 hours after extubation
Mean arterial blood pressure (MAP)
Mean arterial blood pressure (MAP) will be assessed before induction of anesthesia, immediately after intubation, after first recruitment Maneuvere (RM), one hour after pneumoperitoneum, after second recruitment Maneuvere (RM), and one hour after extubation.
Measured: One hour after extubation
Heart rate
Heart rate (HR) will be assessed before induction of anesthesia, immediately after intubation, after first recruitment Maneuvere (RM), one hour after pneumoperitoneum, after second recruitment Maneuvere (RM), and one hour after extubation.
Measured: One hour after extubation
Postoperative pulmonary complication
Early postoperative pulmonary complication in the first 24 hours postoperative.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start12 Mar 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Guided Recruitment ManauvereStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mostafa Mostafa Rezk, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306820
- Sponsor's protocol ID
- 36264MS257/7/2023
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery; A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06306820
- Acronym / sponsor ID
- 36264MS257/7/2023
- Conditions
- Ultrasound Guided Recruitment Manauvere, End Expiratory Pressure, Pediatric Patients, Laparoscopic Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Mar 2024 (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 aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.
Detailed description
Atelectasis is among the most frequent postoperative pulmonary complications (PPCs) of general anesthesia with an incidence of between 68% and 100% in children. Atelectasis impairs gas exchange, thus causing hypoxemia and other respiratory disorders such as acute lung injury and pneumonia.
Pneumoperitoneum is another risk factor for perioperative atelectasis. It elevates the diaphragm and intra-abdominal pressure. In order to prevent atelectasis, applying positive end-expiratory pressure (PEEP) or an alveolar recruitment Maneuvere (RM) have shown beneficial effects.
Lung ultrasound (US) is a noninvasive, radiation-free, convenient, and reproducible bedside imaging modality for anesthesia-induced atelectasis in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Fixed PEEPPatients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O. |
| Ultrasound group | Experimental | Other: Ultrasound-guided lung recruitmentPatients will receive ultrasound -guided lung recruitment. |
| PEEP IND group | Experimental | Other: Individualized PEEPPatients will receive individualized positive end-expiratory pressure (PEEP). |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 3 to 8 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Children scheduled for elective laparoscopic abdominal surgeries.
Key exclusion criteria (6 listed)
- Parental refusal.
- Bronchial asthma or any preexisting chest disease.
- Congenital deformity of the thoracic cage.
- Patients with a history of thoracic surgery.
- Cardiac, hepatic, or renal failure.
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 |
|---|---|---|
| Fixed PEEPPatients will receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH2O throughout the surgical procedure. | Other | Control group |
| Ultrasound-guided lung recruitmentPatients will receive ultrasound-guided lung before pneumoperitoneum, after pneumoperitoneum then once an hour, until the end of surgery. Alveolar recruitment will be conducted the same as that for the conventional manoeuvre with a simultaneous continuous ultrasound assessment if atalectasis is detected until no collapsed areas are visualized. When the collapsed lung areas are absent on the sonogram, positive end-expiratory pressure (PEEP) can no longer increase at this point. Subsequently, the pressure will be maintained for approximately 10 breaths. | Other | Ultrasound group |
| Individualized PEEPPatients will receive individualized positive end-expiratory pressure (PEEP). After the first recruitment Maneuvere (RM), titration of PEEP will be performed by setting the initial PEEP to 5 cm H2O, then increasing PEEP according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: [Cstat = VT/Pplat - PEEP] (Pplat = plateau pressure), then gradually increasing PEEP, until the calculated Cstat shows a downward trend, the we set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEP for this patient. The highest PEEP is limited to 15 cmH2O. | Other | PEEP IND group |
Primary outcome
Intraoperative oxygenation
Time frame: One hour after second recruitment Maneuvere
Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen P/F ratio will be assessed before induction of anesthesia, one hour after pneumoperitoneum, and after second recruitment Maneuvere (RM)
4 secondary outcomes
Lung ultrasound scores
Time frame: 24 hours after extubation
Mean arterial blood pressure (MAP)
Time frame: One hour after extubation
Heart rate
Time frame: One hour after extubation
Postoperative pulmonary complication
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed PEEP, Ultrasound-guided lung recruitment and Individualized PEEP in people with Ultrasound Guided Recruitment Manauvere and End Expiratory Pressure, 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 6 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: status not confirmed, as of the sponsor's last update on 13 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham M Rezk, MBBCH (00201013193723, rehamrezk95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative oxygenation (time frame: One hour after second recruitment Maneuvere). 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 13 Mar 2024.