Clinical Trials Directory

Trials / Completed

CompletedNCT04150276

Obesity, PEEP and Postoperative Oxygenation

Zero Positive End-expiratory Pressure Before Emergence Improves Postoperative Oxygenation in Obese Patients Undergoing Laparoscopic Surgery - a Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Region Västmanland · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREZEEP during awakeningZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.
PROCEDUREPEEP during awakeningPEEP will be maintained throughout emergence preoxygenation and awakening.

Timeline

Start date
2019-12-03
Primary completion
2023-01-25
Completion
2023-01-25
First posted
2019-11-04
Last updated
2023-01-26

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04150276. Inclusion in this directory is not an endorsement.