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Obesity, PEEP and Postoperative Oxygenation (ZAPPAII)

R

Region Västmanland

Status

Completed

Conditions

Oxygenation

Treatments

Procedure: PEEP during awakening
Procedure: ZEEP during awakening

Study type

Interventional

Funder types

Other

Identifiers

NCT04150276
Dnr 2019/04860

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

ZEEP during awakening
Active Comparator group
Description:
ZEEP will be used during emergence preoxygenation and awakening.
Treatment:
Procedure: ZEEP during awakening
PEEP during awakening
Active Comparator group
Description:
PEEP is maintained throughout emergence preoxygenation and awakening.
Treatment:
Procedure: PEEP during awakening

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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