Obesity, PEEP and Postoperative Oxygenation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2023-01-25

Brief Summary

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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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Detailed Description

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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

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Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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ZEEP during awakening

ZEEP will be used during emergence preoxygenation and awakening.

Group Type ACTIVE_COMPARATOR

ZEEP during awakening

Intervention Type PROCEDURE

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

PEEP during awakening

PEEP is maintained throughout emergence preoxygenation and awakening.

Group Type ACTIVE_COMPARATOR

PEEP during awakening

Intervention Type PROCEDURE

PEEP will be maintained throughout emergence preoxygenation and awakening.

Interventions

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ZEEP during awakening

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

Intervention Type PROCEDURE

PEEP during awakening

PEEP will be maintained throughout emergence preoxygenation and awakening.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No