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

NCT03351946 | Completed

• 1 other identifier: Dnr 2017/267
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis; Oxygenation

Keywords

Atelectasis; Oxygenation; Positive end-expiratory pressure; Mechanical ventilation; General anesthesia; Computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in oxygenation

  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.

Study Arms (2)

ZEEP at awakening

ACTIVE COMPARATOR

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.

Procedure: ZEEP

PEEP at awakening

ACTIVE COMPARATOR

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.

Procedure: PEEP

Interventions

ZEEP PROCEDURE

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

Also known as: Device: Ventilatory setting ZEEP

ZEEP at awakening

PEEP PROCEDURE

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

Also known as: Device: Ventilatory setting PEEP

PEEP at awakening

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) class I-II
• Non-abdominal day case surgery under general anesthesia

You may not qualify if:

• 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).

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Department of Anaesthesia and Intensive Care

Köping, Sweden

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lennart Edmark, M.D., Ph.D.

  Region Västmanland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sealed envelopes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 24, 2017
• Study Start: December 4, 2017
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by a review panel at the Center for Clinical Research, Västerås. Requestors will be required to sign a data acess agreement.

Locations

SE (1)