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Completed

NCT Number: NCT04150276

Obesity, PEEP and Postoperative Oxygenation

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Anaesthesia and Intensive Care

Västerås, Region Västmanland, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZEEP during awakening

Procedure

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

PEEP during awakening

Procedure

PEEP will be maintained throughout emergence preoxygenation and awakening.

Primary outcomes

  1. Change in oxygenation

    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.

Secondary outcomes

  1. Need for postoperative supplemental oxygen

    Time frame: First 3 hours postoperatively.

    Number of patients and amount of oxygen needed in the respective group postoperatively.

Sponsors and collaborators

Lead sponsor

Region Västmanland

Other

Registry information

Official study title

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

Acronym: ZAPPAII

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2019
Registry last updated
Jan 26, 2023

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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