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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04150276
Acronym
ZAPPAII
Enrollment
60
Registered
2019-11-04
Start date
2019-12-03
Completion date
2023-01-25
Last updated
2023-01-26

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

Conditions

Oxygenation

Keywords

Oxygenation, Positive end-expiratory pressure, General anaesthesia, Obesity, Atelectasis, Mechanical ventilation

Brief 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.

Interventions

PROCEDUREZEEP during awakening

ZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.

PROCEDUREPEEP during awakening

PEEP will be maintained throughout emergence preoxygenation and awakening.

Sponsors

Region Västmanland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Obese patients scheduled for elective laparocopic surgery. * American Society of Anesthesiologists functional class I-III * Body Mass Index 35-50 kg/m2

Exclusion criteria

* Body Mass Index ≥50 kg/m2 * Peripheral oxygen saturation (SpO2) breathing air \<94 % * Symtomatic asthma, COPD or heart failure * Ischemic heart disease * Hemoglobin \< 100g/l * Smokers and ex-smokers that stopped smoking \< 9 months ago * Need for peroperative RM and PEEP higher than in study protocol, as indicated by SpO2 \<92% despite the stipulated FiO2 0.30-0.35. * Obstructive sleep apnea syndrome on home-CPAP

Design outcomes

Primary

MeasureTime frameDescription
Change in oxygenationBloodgases 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.

Secondary

MeasureTime frameDescription
Need for postoperative supplemental oxygenFirst 3 hours postoperatively.Number of patients and amount of oxygen needed in the respective group postoperatively.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026