An interventional study of Standard PEEP ventilation and Matched PEEP ventilation in Anesthesia, General/Methods, Laparoscopy and Respiration, Artificial, sponsored by Hospital Universitario La Fe. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by Hospital Universitario La Fe · Not applicable, Interventional, and Diagnostic
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Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled with different ventilatory positive end-expiratory pressure levels affects the transpulmonary driving pressure during pneumoperiteneum insufflation for laparoscopic surgery.
Methodology: Patients undergoing laparoscopic surgery will be included. The study will investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary driving pressure (TpDp) and the effect of titration of PEEP on their relationship.
At three different levels of intra-abdominal pressure, the respiratory driving pressure (RDp) and TpDp in each subject will be measured in each subject. The same subject will undergo two different ventilation strategies. Demographic data (height, weight, body mass index and sex), ASA physical status (surgical risk classification of the American Society of Anesthesiology), number of previous abdominal surgeries, number of previous pregnancies, and respiratory comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables recorded will include: airway pressures (Plateau pressure Pplat, Peak pressure, Ppeak), the final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed linear regression will be used to evaluate the relationship between different PEEP levels, IAP and TpDp by adjusting for known confounders and adding individuals as a random factor. Likewise, an analysis using a mixed linear regression model with the pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime, and a specific random intercept term for each subject will be performed.
121 studies on the registry are indexed under Ventilator-Induced Lung Injury; 39 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 75 interventional studies indexed under Ventilator-Induced Lung Injury.
Browse Ventilator-Induced Lung Injury studies →Hospital Universitario La Fe is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and 5 cmH20 of PEEP at every intra-abdominal pressure (IAP) step (8, 12 and 15 mmHg).
Other: Standard PEEP ventilation · Other: Matched PEEP ventilation
During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and a level of PEEP matched to every IAP step (8, 12 and 15 mmHg). 1 mmHg = 1,36 cmH20. Between the standard and matched PEEP intervention there is a washout period that with a recruitment maneuver to re-establish baseline lung condition.
Other: Standard PEEP ventilation · Other: Matched PEEP ventilation
During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation
During mechanical ventilation PEEP is matched to IAP level
Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation
TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)
TpDp (in cmH20) is recorded at different levels of IAP and with two different PEEP settings (in cmH20; two levels are: fixed at each IAP level, standard group and matched at each IAP level, matched group). The relationship between TpDp and IAP (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).
Respiratory driving pressure (transpulmonary driving pressure + pressure to move the chest wall, in cmH20, RpDp) and TpDp relationship at each IAP and PEEP level will be assessed. The relationship between TpDp and RpDp (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Respiratory system compliance (Crs) difference between standard and matched PEEP levels
Respiratory system compliance measures the system's ability to stretch. It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20)
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Pulmonary compliance (Cp) difference
Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Chest wall compliance (CCw) difference
Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Pulmonary Stress index difference
Stress index is based on respiratory pressure curve analysis and assess whether the lungs are overdistended or collapsed
Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Plan to share: No
Ran from Apr 2018 to primary completion in Nov 2018, 7 months.
Of 40 interventional studies with no phase under Ventilator-Induced Lung Injury, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 7 months is below that.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Fe