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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03351946
Other study ID # Dnr 2017/267
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2017
Est. completion date August 28, 2018

Study information

Verified date September 2018
Source Region Västmanland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study on healthy patients undergoing anesthesia for non-abdominal surgery - evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure on the amount of atelectasis in the early postoperative period.


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 has been 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 prevent postoperative atelectasis formation.

This randomized controlled study will study patients undergoing non-abdominal day case surgeries under general anesthesia. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, moderate PEEP, and no RM. At the end of surgery, the lungs will be examined by CT, and any atelectasis areas will be calculated. Randomization will occur after the first CT. 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. The study subjects will be examined with CT no.2 approximately thirty min after extubation. Primary endpoint measure will be atelectasis area as a percentage of total lung area. Blood gases will be collected for comparison of oxygenation as a secondary outcome measure.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 28, 2018
Est. primary completion date August 28, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiology (ASA) class I-II

- Non-abdominal day case surgery under general anesthesia

Exclusion Criteria:

- Body mass index (BMI) =30 kg/m2

- Arterial oxygen saturation (SpO2) breathing air <95 %

- Chronic Obstructive Pulmonary Disease (COPD) or symptomatic asthma

- Symptomatic congestive heart failure

- Ischemic heart disease

- Hemoglobin <100 g/L

- Active smokers

- Active smokers and ex-smokers with a history of more than 6 pack years.

- Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ZEEP
Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.
PEEP
Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.

Locations

Country Name City State
Sweden Department of Anaesthesia and Intensive Care Köping

Sponsors (1)

Lead Sponsor Collaborator
Region Västmanland

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in atelectasis area Atelectasis area as studied by computed tomography. Within 3 hours from induction of anesthesia. First CT after surgery, before emergence. Second CT approx 25 min after extubation. Study complete after that, no further CT.
Secondary Change in oxygenation Arterial blood samples will be collected for measurement of arterial oxygen partial pressure. Within 3 hours from induction of anesthesia. First blood gas after surgery, before emergence. Second approx 25 min after extubation. Study complete after that, no further blood gases.
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