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How to practically adjust artificial ventilation to protect the lungs during stomach reduction surgery.

Evaluation of Strategies for Positive Pressure Rapid Adjustment at the End of Expiration in Laparoscopic Surgery with pneumoperitoneum in Obese patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-68y7cz
Enrollment
Unknown
Registered
2018-09-28
Start date
2016-07-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Protocol Twenty patients will be included in each study group and all patients will follow the same procedures until de ventilation per surgery. Anesthesia protocol and preoperative care, including th
VT = 8 ml / kg body weight
FR between 10-20 irpm adjusted for normocapnia (PEtCO2 = 35-45 mmHg)
I: E = 1: 2
PEEP = 5 cmH 2 O and FIO 2 = between 50-60%
In this period the signs of mechanics and hemodynamics will be continuously recorded until the performance of the pneumoperitoneum Next, the pneumoperitoneum will be performed according to the clinica
Procedure/surgery

Sponsors

Hospital Federal dos Servidores do Estado
Lead Sponsor
Instituto de Biofísica Carlos Chagas Filho- UFRJ
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Will be selected for the present study adult patients with obesity class III with BMI> 40 kg / m2; more than 18 years old followed by the bariatric surgery and endocrinology services of the Servidores do Estado do Rio de Janeiro Federal Hospital and will perform bariatric surgery.

Exclusion criteria

Exclusion criteria: Patients or legal guardians who do not agree to participate in the study or do not authorize the participation of patients under their responsibility will be excluded from the study; patients who have not signed the term of free and informed consent before the procedure; patients with diagnosed lung disease; patients with diagnosed heart failure; patients with chest wall alterations with different cause by obesity.

Design outcomes

Primary

MeasureTime frame
Outcome 1 Compare the effect of ventilation with PEEP adjusted by the minimum elastance and a standard ventilation with 5 cmH2O of PEEP in the ventilatory mechanics of patients undergoing bariatric surgery with pneumoperitoneum. Values ??to be analyzed Driving Pressure Elastância Airway resistance During the protocol, flow and airway pressure values ??will be continuously purchased from the anesthesia machine itself via a serial interface connected to a portable computer. three periods of three to five minute of the acquired signals will be analyzed offline, corresponding to the initial period, final minutes and a mid-length stretch of the surgery. After the surgeries, the signals acquired by the ventilator will be imported by MECANICA software and reprocessed offline. The Paw, flow and volume signals will be used for the off-line elastance estimation (ESR) and respiratory system resistance (RSR) with the least squares cycle-to-cycle method (MMQ) considering the unicompartmental mathematical model.;Outcome 2 Compare the effect of ventilation with PEEP adjusted by the minimal elastance in the oxygenation of patients undergoing bariatric surgery with pneumoperitoneum. 5 ml of arterial blood will be collected at two moments of surgery. Soon after the installation of the pneumoperitoneum and another after the suture of the stomach with the pneumoperitoneum still. The blood will be analyzed by a blood gas analyzer. Variables whose values will be analyzed: oxygen partial pressure (PaO2) partial pressure of carbon dioxide (PaCO2) Oxygenation index (PaO2 / FiO2)

Secondary

MeasureTime frame
Outcome 1 Evaluate the effects of PEEP adjusted by the minimal elastance in the hemodynamics of obese patients submitted to laparoscopic surgery with pneumoperitoneum. Throughout the entire procedure the invasive blood pressure signal will be acquired and three periods of three to five minute of the acquired signals will be analyzed offline, corresponding to the initial period, final minutes and a mid-length stretch of the surgery. Dose of vasopressure medication used and hydration volume during surgery will be acquired form de data report of anaesthesiologist from the Hospital anaesthesia department. Variables whose values will be analyzed: Mean blood pressure (MAP) Systolic blood pressure (Psist) Diastolic Blood Pressure (Pdias) Dose of vasopressor drugs Volume of venous hydration

Countries

Brazil

Contacts

Public ContactAlysson;Marcelo Roncally;Duran

Instituto de Biofísica Carlos Chagas Filho- UFRJ;Hospital Federal dos Servidores do Estado

roncally.carvalho@gmail.com;duran.ms@gmail.com+552198591077;+5521981517689

Outcome results

None listed

Source: REBEC (via WHO ICTRP)