Abdominal SurgeryNCT04506736
Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery
A study testing ARM and spontanous ventilation in people with Abdominal Surgery and Obese Patients, run by Zagazig University at 1 site in Egypt.
Trial summary
the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Surgery, Obese Patients
- What is being tested?
- ARM and spontanous ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2020to 30 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged between 18 - 65 years
- BMI between 30-40 kg/m²
- ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery
Who cannot join
- Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 < 80% of the predicted value)
- active asthma, acute respiratory distress syndrome
- history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
- significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine,Zagazig University
Zagazig, Zagazig, Elsharkia,egypt, 44519
About this study
Official title: Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial
the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery
Read the detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Group OLA: The patients will undergo ARM followed by personalized PEEP.
- Conditions
- Abdominal Surgery, Obese Patients
- Being tested
- ARM, spontanous ventilation
- Keywords
- Open lung approach, conventional ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARMOther
Also called followed by personalized PEEP.
The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O.
The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.
spontanous ventilationOther
volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
| Study group | Role | What they receive |
|---|---|---|
| SPV spontanous ventilation | Active comparator | The patients will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery . Receives: Other: spontanous ventilation |
| OLA open lung ventilation | Active comparator | The patients will undergo ARM followed by personalized PEEP. Receives: Other: ARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pulmonary complications
Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.
Measured: one week postoperative
Secondary outcomes (8)
heart rate
hemodynamic changes
Measured: Baseline (before surgery) and intraoperative
airway pressure
During mechanical ventilation airway pressures will be continuously monitored.
Measured: intraoperative
pulmonary complications.
- Postoperative pulmonary complications which are defined as having one or more of the following: 1.Pneumonia 2. Respiratory failure requiring mechanical ventilation (Postoperative PaO2 < 60 mm Hg on room air, a PaO2:FiO2 ratio < 300 mm Hg) or peripheral oxygen saturation (SpO₂) <90% and requiring oxygen therapy ). 3. Atelectasis requiring bronchoscopic intervention 4. Pulmonary edema ( postoperative acute lung injury or ARDS). 5. Delayed tracheal extubation ( >24 hours postoperatively) or need for reintubation (because of respiratory distress, hypoxia, hypercarbia, or respiratory acidosis). 6. Pneumothorax 7. Bronchospasm (Newly detected refractory expiratory wheeze requiring bronchodilators
Measured: one week postoperative
length of hospital stay,
the length of hospital stay, and 30 days mortality.
Measured: postoperative up to one month
mean arterial blood pressure
hemodynamic changes
Measured: Baseline (before surgery) and intraoperative
ETCO2
hemodynamic changes
Measured: Baseline (before surgery) and intraoperative
tidal volume
During mechanical ventilation tidal volume will be continuously monitored.
Measured: intraoperative
SpO2
hemodynamic changes
Measured: Baseline (before surgery) and intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start15 Aug 2020
- Primary completion30 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- Howida A kamal, M.D, Study director, zagazig U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506736
- Sponsor's protocol ID
- 6204
- Status last verified
- May 2022
- First submitted
- 24 Jul 2020
- Last updated
- 24 May 2022
- 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04506736
- Acronym / sponsor ID
- 6204
- Conditions
- Abdominal Surgery, Obese Patients
- Keywords
- Open lung approach, conventional ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 10 Aug 2020 (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 purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery
Detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Group OLA: The patients will undergo ARM followed by personalized PEEP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPV spontanous ventilation | Active comparator | Other: spontanous ventilationThe patients will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery . |
| OLA open lung ventilation | Active comparator | Other: ARMThe patients will undergo ARM followed by personalized PEEP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged between 18 - 65 years
- BMI between 30-40 kg/m²
- ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery
Key exclusion criteria (4 listed)
- Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 < 80% of the predicted value)
- active asthma, acute respiratory distress syndrome
- history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
- significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension
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 |
|---|---|---|
| ARMAlso: followed by personalized PEEP.The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O. The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step. | Other | OLA open lung ventilation |
| spontanous ventilationvolume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery . | Other | SPV spontanous ventilation |
Primary outcome
post-operative pulmonary complications
Time frame: one week postoperative
Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.
8 secondary outcomes
heart rate
Time frame: Baseline (before surgery) and intraoperative
airway pressure
Time frame: intraoperative
pulmonary complications.
Time frame: one week postoperative
length of hospital stay,
Time frame: postoperative up to one month
mean arterial blood pressure
Time frame: Baseline (before surgery) and intraoperative
ETCO2
Time frame: Baseline (before surgery) and intraoperative
tidal volume
Time frame: intraoperative
SpO2
Time frame: Baseline (before surgery) and intraoperative
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 24 May 2022.
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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.
Howida A kamal, M.D study director
zagazig U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARM and spontanous ventilation in people with Abdominal Surgery and Obese Patients, run by Zagazig 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 3 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 24 May 2022. 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?
post-operative pulmonary complications (time frame: one week postoperative). 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 24 May 2022.