Zero Positive End-expiratory Pressure Before Emergence Prevents Postoperative Atelectasis.

NCT ID: NCT03351946

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2018-08-28

Brief 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.

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 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.

Conditions

Atelectasis; Oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ZEEP at awakening

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) until start of emergence preoxygenation.

Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.

First CT scan after completion of surgery, before emergence. After the first CT scan and immediately before start of emergence preoxygenation, this group will have the PEEP exchanged for zero PEEP (ZEEP). ZEEP will remain until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

Group Type: ACTIVE_COMPARATOR

ZEEP

Intervention Type: PROCEDURE

Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.

PEEP at awakening

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) even after start of emergence preoxygenation.

Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.

First CT scan after completion of surgery, before emergence. After the first CT scan, this group will have PEEP remained until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

Group Type: ACTIVE_COMPARATOR

PEEP

Intervention Type: PROCEDURE

Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.

Interventions

ZEEP

Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.

Intervention Type: PROCEDURE

PEEP

Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.

Intervention Type: PROCEDURE

Other Intervention Names

Device: Ventilatory setting ZEEP; Device: Ventilatory setting PEEP

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västmanland

OTHER

Sponsor Role: lead

Responsible Party

Erland Ostberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lennart Edmark, M.D., Ph.D.

Role: STUDY_DIRECTOR

Region Västmanland

Locations

Department of Anaesthesia and Intensive Care

Köping, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2017/267

Identifier Type: -

Identifier Source: org_study_id