Pulmonary Atelectasis, PostoperativeLUS/PEEP/RMNCT06654778
Ultrasound Evaluation of Preventive Measures for Postoperative Lung Atelectasis After Surgery
A study testing PEEP, PEEP/RM and PEEP/RM/RF in people with Pulmonary Atelectasis, Postoperative, run by Al-Azhar University at 1 site in Egypt.
Trial summary
the aim of this prospective randomized blinded clinical study will be to assess the ultrasound evaluation of different preventive measures of post operative lung atelectasis in abdominal surgeries; these measures include ventilation and fluid measures Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Pulmonary Atelectasis, Postoperative
- What is being tested?
- PEEP, PEEP/RM and PEEP/RM/RF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Dec 2024to 19 Dec 2025
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I or II, of either gender.
- BMI < 40
- Age 30-60 years
- scheduled for elective abdominal surgeries
Who cannot join
- Patient refusal
- American Society of Anesthesiologists (ASA) physical status classification system more than II
- BMI > 40 .
- Psychiatric disorders
- History of chest disorders such as asthma and obstructive pulmonary disease (COPD).
- History of Previous Thoracic Procedures.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Evaluation of Different Preventive Measures of Post Operative Lung Atelectasis After Upper Abdominal Surgeries: Ventilation and Fluid Measures
the aim of this prospective randomized blinded clinical study will be to assess the ultrasound evaluation of different preventive measures of post operative lung atelectasis in abdominal surgeries; these measures include ventilation and fluid measures
Read the detailed description
ultrasound evaluation for application of different preventive measures of post operative lung atelectasis, including positive end-expiratory pressure, lung recruitment maneuvers, and restrictive fluid management.
- Conditions
- Pulmonary Atelectasis, Postoperative
- Being tested
- PEEP, PEEP/RM, PEEP/RM/RF
- Keywords
- lung ultrasound, lung Atelectasis, Atelectasis, Pulmonary Atelectasis, pressure controlled ventilation - volume guarantee (PCV- VG), positive end-expiratory pressure (PEEP), lung recruitment maneuver, restrictive fluid strategies
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
Patients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery.
PEEP/RMOther
Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery
PEEP/RM/RFOther
Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF). Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I: PEEP | Experimental | Patients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery. Receives: Other: PEEP |
| Group II: PEEP/RM | Experimental | Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery Receives: Other: PEEP/RM |
| Group III: PEEP/RM/RF | Experimental | Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF). Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery Receives: Other: PEEP/RM/RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery.
The Lung Ultrasound Score (LUS): the key points based on ultrasound findings:
- 0 points: (N) Normal aeration (presence of lung sliding with A-lines or <2 separate B-lines).
II. 1 point: (B1) Moderate loss of lung aeration (≥3 well-defined B lines). III. 2 points: (B2) Severe loss of lung aeration (coalescing B-lines). IV. 3 points: (C) Complete loss of lung aeration (pulmonary consolidations). Total Score: points will be distributed according to the worst ultrasound pattern observed: N = 0, B1 lines = 1, B2 lines = 2, C = 3. The LUS score ranging between 0 and 36 was calculated as the sum of points.
Measured: at the end of surgery before emergence from GA.
Secondary outcomes (7)
Lung ultrasound assessment
Lung ultrasound assessment of atelectasis
Measured: before induction of general anesthesia
Lung ultrasound assessment
Lung ultrasound assessment of atelectasis
Measured: 5 minutes post induction of general anesthesia
Lung ultrasound assessment
Lung ultrasound assessment of atelectasis
Measured: 15 minutes after patients arrive to PACU
Lung ultrasound assessment
Lung ultrasound assessment of atelectasis
Measured: 60 minutes after patients arrive to PACU
arterial blood gases
Pao2, spo2, paco2, pao2/fio2
Measured: 5 minutes post induction of general anesthesia
arterial blood gases
Pao2, spo2, paco2, pao2/fio2
Measured: before emergence from general anesthesia
arterial blood gases
Pao2, spo2, paco2, pao2/fio2
Measured: 15 minutes after patients arrive to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start8 Dec 2024
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Atelectasis, PostoperativeStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- The patients will be assigned into three equal groups of 20 patients each: 1. Group I: PEEP of 8 cm H2O and fluid management: 500 ml + 4 mL/kg/hour Ringer's lactate 2. Group II: PEEP/RM group, addition of RM (30 cm H2O for 30 s) 3. Group III: PEEP/RM group and restricted fluid management 3 mL/kg/hour Ringer's lactate A total sample size of 60 patients will be involved.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamed Mohamed Wally Allah, Al-Azhar University
- Investigators
- Hamed M Wally Allah, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654778
- Sponsor's protocol ID
- AZAST/MD/209/MARCH/2024
- Acronym
- LUS/PEEP/RM
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Different Preventive Measures of Post Operative Lung Atelectasis After Upper Abdominal Surgeries: Ventilation and Fluid Measures
- ClinicalTrials.gov ID
- NCT06654778
- Acronym / sponsor ID
- LUS/PEEP/RM / AZAST/MD/209/MARCH/2024
- Conditions
- Pulmonary Atelectasis, Postoperative
- Keywords
- lung ultrasound, lung Atelectasis, Atelectasis, Pulmonary Atelectasis, pressure controlled ventilation - volume guarantee (PCV- VG), positive end-expiratory pressure (PEEP), lung recruitment maneuver, restrictive fluid strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 8 Dec 2024 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 23 Oct 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 blinded clinical study will be to assess the ultrasound evaluation of different preventive measures of post operative lung atelectasis in abdominal surgeries; these measures include ventilation and fluid measures
Detailed description
ultrasound evaluation for application of different preventive measures of post operative lung atelectasis, including positive end-expiratory pressure, lung recruitment maneuvers, and restrictive fluid management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- The patients will be assigned into three equal groups of 20 patients each: 1. Group I: PEEP of 8 cm H2O and fluid management: 500 ml + 4 mL/kg/hour Ringer's lactate 2. Group II: PEEP/RM group, addition of RM (30 cm H2O for 30 s) 3. Group III: PEEP/RM group and restricted fluid management 3 mL/kg/hour Ringer's lactate A total sample size of 60 patients will be involved.
| Arm | Type | Receives |
|---|---|---|
| Group I: PEEP | Experimental | Other: PEEPPatients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery. |
| Group II: PEEP/RM | Experimental | Other: PEEP/RMPatients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery |
| Group III: PEEP/RM/RF | Experimental | Other: PEEP/RM/RFPatients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF). Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I or II, of either gender.
- BMI < 40
- Age 30-60 years
- scheduled for elective abdominal surgeries
Key exclusion criteria (7 listed)
- Patient refusal
- American Society of Anesthesiologists (ASA) physical status classification system more than II
- BMI > 40 .
- Psychiatric disorders
- History of chest disorders such as asthma and obstructive pulmonary disease (COPD).
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 |
|---|---|---|
| PEEPPatients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery. | Other | Group I: PEEP |
| PEEP/RMPatients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery | Other | Group II: PEEP/RM |
| PEEP/RM/RFPatients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF). Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery | Other | Group III: PEEP/RM/RF |
Primary outcome
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery
Time frame: at the end of surgery before emergence from GA.
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery. The Lung Ultrasound Score (LUS): the key points based on ultrasound findings: I. 0 points: (N) Normal aeration (presence of lung sliding with A-lines or <2 separate B-lines). II. 1 point: (B1) Moderate loss of lung aeration (≥3 well-defined B lines). III. 2 points: (B2) Severe loss of lung aeration (coalescing B-lines). IV. 3 points: (C) Complete loss of lung aeration (pulmonary consolidations). Total Score: points will be distributed according to the worst ultrasound pattern observed: N = 0, B1 lines = 1, B2 lines = 2, C = 3. The LUS score ranging between 0 and 36 was calculated as the sum of points.
7 secondary outcomes
Lung ultrasound assessment
Time frame: before induction of general anesthesia
Lung ultrasound assessment
Time frame: 5 minutes post induction of general anesthesia
Lung ultrasound assessment
Time frame: 15 minutes after patients arrive to PACU
Lung ultrasound assessment
Time frame: 60 minutes after patients arrive to PACU
arterial blood gases
Time frame: 5 minutes post induction of general anesthesia
arterial blood gases
Time frame: before emergence from general anesthesia
arterial blood gases
Time frame: 15 minutes after patients arrive to PACU
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 26 Dec 2025.
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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.
Hamed M Wally Allah principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP, PEEP/RM and PEEP/RM/RF in people with Pulmonary Atelectasis, Postoperative, run by Al-Azhar 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 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 26 Dec 2025. 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?
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery (time frame: at the end of surgery before emergence from GA.). 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 26 Dec 2025.