Ventilation Strategy Reduces Postoperative Atelectasis

Pulmonary Atelectasis Clinical Trial

Official title:

Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01911923
• Other study ID #: Dnr 2008 / 251
• Status: Withdrawn
• Phase: N/A
• First received: July 26, 2013
• Last updated: August 25, 2014
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Landstinget Västmanland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis.

Description:

During general anesthesia, the combination of reduced functional residual capacity (FRC), high inspiratory oxygen fraction (FIO2), and airway closure are the main factors implicated in the atelectasis, shunt and shunt-like effects that account for the majority of the impaired oxygenation seen during general anesthesia.

Previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (CPAP) followed by a positive end-expiratory pressure (PEEP).During emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. Even a recruitment maneuver, followed by ventilation with 100% oxygen with a PEEP/CPAP of 10 cm H2O until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (ZEEP).This failure may have been caused by the presence of lung regions with high oxygen concentrations.

The investigators hypothesized that by inducing and discontinuing anesthesia during CPAP/PEEP and deliberately reducing FIO2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. To test our hypothesis, the investigators studied 1) a control group with no CPAP/PEEP and a FIO2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on CPAP/PEEP of 6 cmH2O from induction to extubation and that received an FIO2 of 1.0 until extubation and then an FIO2 of 0.3 via a facemask while on CPAP after extubation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult patients up to 75 years of age.

2. American Society of Anesthesiologists (ASA) physical status class I-III.

3. Be able to climb two flight of stairs without stopping.

4. SpO2 of = 94% when breathing air in the supine position.

5. A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of < 31.

Exclusion Criteria:

1. Patients with chronic obstructive pulmonary disease.

2. Smokers.

3. Ex smokers if smoked more than 5 pack years.

4. Overt heart failure

5. Known or predicted difficult intubation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Intervention

Procedure:
• No CPAP/PEEP and 100 % oxygen
This is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled.
• CPAP/PEEP and 30 % oxygen
During all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used.

Locations

Country	Name	City	State
Sweden	Västmanlands sjukhus Köping	Köping	Västmanland

Sponsors (1)

Lead Sponsor	Collaborator
Landstinget Västmanland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of atelectasis	The area of atelectasis is investigated by computed tomography of the lungs postoperatively	30 minutes	Yes
Secondary	Peripheral oxygen saturation (SpO2)	SpO2 is assessed immediately after extubation and then continuously postoperatively	2 hours	Yes