Dep. of Anaesthesia and Intensive Care
Västerås, Region Västmanland, Sweden
NCT Number: NCT04150276
A study on overweight patients undergoing anesthesia for laparoscopic surgery.
- evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Västerås, Region Västmanland, Sweden
Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to preserve end-expiratory lung volume. After emergence and extubation, this volume will diminish instantly. Some patients will have difficulties to restore functional residual capacity (FRC) during the early phase of recovery. If routine high FIO2 is being delivered together with maintained PEEP prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. The investigators hypothesize that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby diminishing postoperative atelectasis formation and improve oxygenation.
This randomized controlled study will study overweight patients undergoing general anesthesia for laparoscopic surgery. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, PEEP, and no RM. Randomization will occur at the end of surgery, before awakening. The patients will be allocated to zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the intervention group will have ZEEP established while still having low ETO2 levels, prior to any preoxygenation. Arterial blood gases will be collected before, during and after anaesthesia. Primary endpoint measure will be change in oxygenation from before awakening to after awakening.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.
PEEP will be maintained throughout emergence preoxygenation and awakening.
Time frame: Bloodgases will be obtained 5 minutes before the start of the awakening procedure and 30 minutes after awakening and extubation.
Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.
Time frame: First 3 hours postoperatively.
Number of patients and amount of oxygen needed in the respective group postoperatively.
Region Västmanland
Other
Zero Positive End-expiratory Pressure Before Emergence Improves Postoperative Oxygenation in Obese Patients Undergoing Laparoscopic Surgery - a Randomized Clinical Trial
Acronym: ZAPPAII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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