Atelectasis, PostoperativeNCT06221449
Lung Recruitment in Laparoscpic Surgery
A study testing Positive end expiratory pressure in people with Atelectasis, Postoperative, run by Menoufia University at 1 site in Egypt.
Trial summary
The goal of this clinical trial study is to assess the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Postoperative
- What is being tested?
- Positive end expiratory pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 15 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with healthy lungs
- Age between 18 and 65 years old
- Body mass index (BMI) <30 kg / m2
- Physical status I-II of the American Society of Anesthesiologists (ASA)
- Elective laparoscopic cholecystectomy.
Who cannot join
- Patient refusal
- Patients with preoperative ultrasound evidence of pulmonary atelectasis.
- Patients who will have conversion from laparoscopic to open surgery.
- Patients experiencing critical postoperative complications such as severe subcutaneous emphysema and pneumothorax.
- Patients with pulmonary, cardiac, and neuromuscular diseases and a corresponding surgical history and respiratory tract infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lung Recruitment on Atelectasis in Lung-Healthy Patients Undergoing Laparoscopic Cholecystectomy
The goal of this clinical trial study is to assess the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise Positive end expiratory pressure increasing group(Third group). Each contains 31 patients.
Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, we will apply sustained inflation by adjusting Adjustible pressure Limiting valve 40 centimetres water on spontaneous mode, holding the bag for 30 second.
Third group = After abdominal deflation, we will apply stepwise Positive Pressure increasing by 2 centimetres water every 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetres water.
Read the detailed description
the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise POSITIVE pressure increasing group. Each contains 31 patients.
Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, The investigators will apply sustained inflation by adjusting Adjustible pressure valve 40 centimetres water spontaneous mode, holding the bag for 30 second.
Third group = After abdominal deflation, the investigators will apply stepwise POSITIVE pressure increasing by 2 centimeters water 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetreswater.
During the entire procedure the transducer head will be placed over one point of the chest selected by the operator where the area of atelectasis was detected The probe will be placed in the atelectasis area.
- Conditions
- Atelectasis, Postoperative
- Being tested
- Positive end expiratory pressure
- Keywords
- laparoscopic, atelectasis, recruitment maneuver,
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end expiratory pressureProcedure or surgery
The patients will be divided into three groups:
Control group:(31 patients); Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate10-14 RR/min) II) Group (II) Sustained inflation group (SI): (31 patients); Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 cmH2O, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate 10-14 RR/min) III) Group (III) Stepwise PEEP increasing: (31 patients); Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in PEEP 2 cmH2O every 5 respiratory cycle with maximum 10-12 cmH2O guided by hemodynamics \& airway pressure not exceeding 40 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Group (I) Control group:(31 patients) | Placebo comparator | Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg Ideal body weight - fixed fio2 0.5% - fixed POSITIVE end expiratory pressure 6 cm. water - fixed respiratory rate10-14 Respiratory rate /min) Receives: Procedure: Positive end expiratory pressure |
| Group (II) Sustained inflation group (SI): (31 patients) | Active comparator | Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 centimetreswater, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg Ideal bogy weight - fixed fio2 0.5% - fixed positive end expiratory pressure 6 cmH2O - fixed respiratory rate 10-14 per minute. Receives: Procedure: Positive end expiratory pressure |
| Group (III) Stepwise PEEP increasing: (31 patients) | Active comparator | Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in Positive end expiratory pressure 2 centimetres water every 5 respiratory cycle with maximum 10-12 centimetres water guided by hemodynamics \& airway pressure not exceeding 40 centimetres water With these parameters (fixed Tidal Volume 6-8ml/Kg Ideal body weight - fixed fio2 0.5% -fixed respiratory rate10-14 . Receives: Procedure: Positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atelectasis
incidence
Measured: one hour
Secondary outcomes (4)
Lung ultrasound score
0 no atelectasis with A lines
- multiple B lines
- white lung
- Lung consolidation
Measured: one day
Blood pressure ( millimetre Mercury)
Measurements
Measured: Two hour
Heart rate
Beat per minute
Measured: Two hour
Hospital length of stay
Duration of stay at hospital in hours
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Feb 2024
- Primary completion1 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectasis, PostoperativeStudies 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
- Sequential
- Model description
- comparison
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Said Abdel Haleem, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221449
- Sponsor's protocol ID
- 7/2023ANET14
- Status last verified
- Oct 2024
- First submitted
- 19 Dec 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lung Recruitment on Atelectasis in Lung-Healthy Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06221449
- Acronym / sponsor ID
- 7/2023ANET14
- Conditions
- Atelectasis, Postoperative
- Keywords
- laparoscopic, atelectasis, recruitment maneuver,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 24 Jan 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 goal of this clinical trial study is to assess the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise Positive end expiratory pressure increasing group(Third group). Each contains 31 patients.
Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, we will apply sustained inflation by adjusting Adjustible pressure Limiting valve 40 centimetres water on spontaneous mode, holding the bag for 30 second.
Third group = After abdominal deflation, we will apply stepwise Positive Pressure increasing by 2 centimetres water every 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetres water.
Detailed description
the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise POSITIVE pressure increasing group. Each contains 31 patients.
Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, The investigators will apply sustained inflation by adjusting Adjustible pressure valve 40 centimetres water spontaneous mode, holding the bag for 30 second.
Third group = After abdominal deflation, the investigators will apply stepwise POSITIVE pressure increasing by 2 centimeters water 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetreswater.
During the entire procedure the transducer head will be placed over one point of the chest selected by the operator where the area of atelectasis was detected The probe will be placed in the atelectasis area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- comparison
| Arm | Type | Receives |
|---|---|---|
| Group (I) Control group:(31 patients) | Placebo comparator | Procedure: Positive end expiratory pressurePatients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg Ideal body weight - fixed fio2 0.5% - fixed POSITIVE end expiratory pressure 6 cm. water - fixed respiratory rate10-14 Respiratory rate /min) |
| Group (II) Sustained inflation group (SI): (31 patients) | Active comparator | Procedure: Positive end expiratory pressurePatients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 centimetreswater, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg Ideal bogy weight - fixed fio2 0.5% - fixed positive end expiratory pressure 6 cmH2O - fixed respiratory rate 10-14 per minute. |
| Group (III) Stepwise PEEP increasing: (31 patients) | Active comparator | Procedure: Positive end expiratory pressurePatients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in Positive end expiratory pressure 2 centimetres water every 5 respiratory cycle with maximum 10-12 centimetres water guided by hemodynamics \& airway pressure not exceeding 40 centimetres water With these parameters (fixed Tidal Volume 6-8ml/Kg Ideal body weight - fixed fio2 0.5% -fixed respiratory rate10-14 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with healthy lungs
Key exclusion criteria (5 listed)
- Patient refusal
- Patients with preoperative ultrasound evidence of pulmonary atelectasis.
- Patients who will have conversion from laparoscopic to open surgery.
- Patients experiencing critical postoperative complications such as severe subcutaneous emphysema and pneumothorax.
- Patients with pulmonary, cardiac, and neuromuscular diseases and a corresponding surgical history and respiratory tract infections.
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 |
|---|---|---|
| Positive end expiratory pressureThe patients will be divided into three groups: Control group:(31 patients); Patients will have controlled mechanical ventilation with these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate10-14 RR/min) II) Group (II) Sustained inflation group (SI): (31 patients); Patients will have controlled mechanical ventilation then after abdominal deflation, sustained inflation for 30 second by applying pressure 40 cmH2O, with 5 these parameters (fixed Tidal Volume 6-8ml/Kg IBW - fixed fio2 0.5% - fixed PEEP 6 cmH2O - fixed respiratory rate 10-14 RR/min) III) Group (III) Stepwise PEEP increasing: (31 patients); Patients will have controlled mechanical ventilation, then after abdominal deflation gradual increasing in PEEP 2 cmH2O every 5 respiratory cycle with maximum 10-12 cmH2O guided by hemodynamics \& airway pressure not exceeding 40 cmH2O. | Procedure or surgery | Group (I) Control group:(31 patients), Group (II) Sustained inflation group (SI): (31 patients), Group (III) Stepwise PEEP increasing: (31 patients) |
Primary outcome
Incidence of atelectasis
Time frame: one hour
incidence
4 secondary outcomes
Lung ultrasound score
Time frame: one day
Blood pressure ( millimetre Mercury)
Time frame: Two hour
Heart rate
Time frame: Two hour
Hospital length of stay
Time frame: One day
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 16 Oct 2024.
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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 Positive end expiratory pressure in people with Atelectasis, Postoperative, run by Menoufia 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 5 inclusion and 5 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 16 Oct 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. Some participants in this study may receive a placebo. 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?
Incidence of atelectasis (time frame: one hour). 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 16 Oct 2024.