Respiratory System MechanicsPEEP_LAP1NCT05702554
Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study
An observational study of Respiratory System Mechanics and Pneumoperitoneum, run by Azienda Ospedaliera di Perugia at 2 sites in Italy.
Trial summary
The present investigation is focused to assess the effects of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory System Mechanics, Pneumoperitoneum
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Aug 2023to 31 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum
Who may be able to join
- Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.
Who cannot join
- Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Università degli Studi di Perugia
Perugia, Umbria, Italy, 06156
Gianmaria Cammarota, 039755783594, gianmaria.cammarota@unipg.it
- Recruiting
Università degli Studi di Perugia
Perugia, 06123
Rachele Simonte, MD, +390755783594, rachele.simonte@gmail.com
About this study
The present investigation is focused to assess the effects of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum
Read the detailed description
Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.
Will be excluded all the patients with the following conditions: American society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheostomy, previous cardio-thoracic surgery, pulmonary hypertension, broncho-pleural fistula, pulmonary emphysema, pneumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.
Thereafter, general anesthesia will be induced, according to current clinical practice and mechanical ventilation will be commenced according to current recommendations.
Following the application of definitive pneumoeritoneum and body position, the recruitment/inflation procedure will be carried out to identify PEEP. PEEP-induced recruitment will be computed with high PEEP set at 15 cmh2o (or higher) and low PEEP set at 5 cmh2o. In case of an airway opening pressure > 5 cmh2o, the airway opening pressure (AOP) will be set as low PEEP and the high PEEP will be set at the value corresponding to AOP+ 10 cmh20. During the procedure, tidal volume will be maintained between 6-8 ml/kg of predicted body weight. On the basis of the recruitment-to-inflation ratio (R/I), PEEP will be set as follows: low PEEP, in presence of R/I < 0,5; high PEEP with R/I ≥ 1.5; PEEP set within low and high PEEP range on clinical decision, if R/I ≥ 0.5 and <1.5.
After 20 min from the onset of mechanical ventilation and 1 hour from PEEP application following pneumoperitoneum and definitive body position, mechanics of the respiratory system for compliance and driving pressure will be assessed.
As an optional evaluation, a lung ultrasound examination will be performed before general anesthesia induction and 1 hour after extubation, before discharging the patient from recovery room.
During anesthesia vital signs will be continuously monitored. On the clinically judgement, arterial blood gases will be carried out across the study stages.
- Conditions
- Respiratory System Mechanics, Pneumoperitoneum
- Medical subject headings
- Pneumoperitoneum
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative respiratory system mechanics
respiratory system compliance defined as volume variation to pressure variation ratio
Measured: 1 hour following PEEP application
Secondary outcomes (1)
respiratory pulmonary complications incidence
the number of pulmonary complications (hypoxaemia with oxygen saturation less than or equal to 92% requiring suplemental oxygen administration, atelectasis, pneumothorax, pneumonia, acute respiratory distress syndrome, reintubation
Measured: up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start5 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory System MechanicsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Gianmaria Cammarota, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702554
- Sponsor's protocol ID
- PEEP_LAP1
- Acronym
- PEEP_LAP1
- Status last verified
- Aug 2023
- First submitted
- 19 Jan 2023
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study
- ClinicalTrials.gov ID
- NCT05702554
- Acronym / sponsor ID
- PEEP_LAP1 / PEEP_LAP1
- Conditions
- Respiratory System Mechanics, Pneumoperitoneum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- 5 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 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.
The present investigation is focused to assess the effects of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum
Detailed description
Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.
Will be excluded all the patients with the following conditions: American society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheostomy, previous cardio-thoracic surgery, pulmonary hypertension, broncho-pleural fistula, pulmonary emphysema, pneumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.
Thereafter, general anesthesia will be induced, according to current clinical practice and mechanical ventilation will be commenced according to current recommendations.
Following the application of definitive pneumoeritoneum and body position, the recruitment/inflation procedure will be carried out to identify PEEP. PEEP-induced recruitment will be computed with high PEEP set at 15 cmh2o (or higher) and low PEEP set at 5 cmh2o. In case of an airway opening pressure > 5 cmh2o, the airway opening pressure (AOP) will be set as low PEEP and the high PEEP will be set at the value corresponding to AOP+ 10 cmh20. During the procedure, tidal volume will be maintained between 6-8 ml/kg of predicted body weight. On the basis of the recruitment-to-inflation ratio (R/I), PEEP will be set as follows: low PEEP, in presence of R/I < 0,5; high PEEP with R/I ≥ 1.5; PEEP set within low and high PEEP range on clinical decision, if R/I ≥ 0.5 and <1.5.
After 20 min from the onset of mechanical ventilation and 1 hour from PEEP application following pneumoperitoneum and definitive body position, mechanics of the respiratory system for compliance and driving pressure will be assessed.
As an optional evaluation, a lung ultrasound examination will be performed before general anesthesia induction and 1 hour after extubation, before discharging the patient from recovery room.
During anesthesia vital signs will be continuously monitored. On the clinically judgement, arterial blood gases will be carried out across the study stages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum
Key inclusion criteria (1 listed)
- Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.
Key exclusion criteria (1 listed)
- Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative respiratory system mechanics
Time frame: 1 hour following PEEP application
respiratory system compliance defined as volume variation to pressure variation ratio
1 secondary outcome
respiratory pulmonary complications incidence
Time frame: up to 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory System Mechanics and Pneumoperitoneum, run by Azienda Ospedaliera di Perugia at 2 sites in Italy.
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 1 inclusion and 1 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 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative respiratory system mechanics (time frame: 1 hour following PEEP application). 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 9 Aug 2023.