Effects of Spontaneous Breathing Activity on Atelectasis Formation During General Anaesthesia (SBAFGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073917
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : October 29, 2010
Information provided by:
Technische Universität Dresden

Brief Summary:
Atelectasis and redistribution of ventilation towards non-dependent lung zones are a common side effects of general anesthesia. Spontaneous breathing activity (SBA) during mechanical ventilation may avoid or reduce atelectasis, improving arterial oxygenation; however, it is unclear whether these effects play a significant role during general anesthesia in patients with healthy lungs. Earlier studies on ventilation during general anesthesia had to rely on computed tomography (CT) findings. Recent advances in lung imaging technology allow to assess the regional aeration of the lungs continuously and non-invasive by electrical impedance technology (EIT). In this work, we will use the EIT to assess ventilation changes from the time before induction of anesthesia until discharge from the post-anesthesia care unit. Our main focus is the difference caused by pure positive pressure ventilation (PCV) and assisted spontaneous breathing (pressure support ventilation, PSV). Our findings would improve our understanding of the physiology of the lungs during general anesthesia and would help to improve the standards of respiratory care during anesthesia

Condition or disease Intervention/treatment Phase
Atelectasis Other: Spontaneous Breathing Other: Pressure Controlled Ventilation Other: Pressure Support Ventilation Not Applicable

Detailed Description:

Atelectasis formation is a common phenomenon during general anaesthesia, occurring in almost 90% of patients (Lundquist, Hedenstierna et al. 1995). In patients in supine position, atelectasis of dorsal lung zones is usually accompanied by redistribution of ventilation towards ventral areas (Hedenstierna 2003; Victorino, Borges et al. 2004).The main mechanisms which contribute to the formation of atelectasis are compression (e.g. in obese patients or during laparoscopic surgery), absorption (e.g. when high concentrations of inspired oxygen are used) and reduced surfactant action(Magnusson and Spahn 2003). Atelectasis impairs oxygenation by reducing the functional residual capacity and by causing right-to-left-shunts. Consecutively, hypoxemia after extubation is common in daily practice: 20% of patients in a study experienced desaturations below 92% (Mathes, Conaway et al. 2001), and the risk is even higher in patients with risk-factors such as obesity or thoraco-abdominal procedures (Russell and Graybeal 1993; Xue, Li et al. 1999). Hypoxemic events prolong the stay in PACU, cause more ICU admissions and increase the incidence of cardiac complications (Rosenberg, Rasmussen et al. 1990; Gill, Wright et al. 1992).

Several measures to prevent or treat atelectasis in ventilated patients have been investigated, such as PEEP (Brismar, Hedenstierna et al. 1985; Tokics, Hedenstierna et al. 1987; Neumann, Rothen et al. 1999), recruitment maneuvers (Neumann, Rothen et al. 1999) and spontaneous breathing during mechanical ventilation (Putensen, Rasanen et al. 1994; Putensen, Mutz et al. 1999). The laryngeal mask airway (LMA) is ideally suited for spontaneous breathing during general anaesthesia because of its low resistance. A large survey found that more than half of the routine cases with an LMA are performed under spontaneous ventilation (Verghese and Brimacombe 1996), while positive pressure ventilation is equally acceptable. With regard to the prevention of atelectasis, spontaneous ventilation could be advantageous.

Most works on atelectasis formation during general anaesthesia used CT. Although CT is a gold standard for quantification of lung aeration, it can only provide data on single time points and is not suitable for measurements during routine cases. In recent years, the electrical impedance tomography (EIT) has evolved into a versatile tool, which allows detailed insights into ventilation and perfusion conditions of the lung (Bodenstein, David et al. 2009). EIT allows continuous assessment of lung aeration, is non-invasive and can easily be used as a research and monitoring tool during routine cases.

We hypothesize that compared with positive pressure ventilation (PPV), pressure support ventilation (PSV) during general anaesthesia reduces the extent of redistribution as detected by EIT during and after the procedure.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of Spontaneous Breathing Activity on Atelectasis Formation During General Anaesthesia: A Randomized Clinical Trial
Study Start Date : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Spontaneous Breathing
Patients will be breathing spontaneously during anesthesia
Other: Spontaneous Breathing
Pressure controlled ventilation
Patients in the PPV group will be ventilated by pressure control (tidal volume 8-10 ml/kg, frequency 10-14, I:E 1:1, no PEEP, target CO2 4.5 kPa).
Other: Pressure Controlled Ventilation
Pressure Support Ventilation
The patients in the PSV group will breathing spontaneously on the ventilator with assistance by inspiratory support pressure. The support pressure will be adjusted to achieve a tidal volume of 8-10 ml/kg.
Other: Pressure Support Ventilation

Primary Outcome Measures :
  1. Regional ventilation at the end of anaesthesia and at discharge from PACU compared to baseline values obtained before induction [ Time Frame: Before, during and after anesthesia ]

Secondary Outcome Measures :
  1. Differences in spirometry values, oxygenation in the PACU (measured as SpO2 at room air), breathing effort [ Time Frame: Before, during and after anesthesia ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients (age 18-65) scheduled for elective knee or ankle surgery under general anaesthesia with an LMA with an expected duration of at least 60 minutes.

Exclusion Criteria:

  • Pregnancy,
  • Pulmonary diseases (e.g. Asthma, COPD),
  • Implanted pacemaker or AICD,
  • Inability to communicate or understand the risks of the study,
  • Contraindications for an LMA (e.g. obesity, reflux),
  • Deformities of the thorax,
  • Failure to place an LMA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073917

University Hospital Carl-Gustav-Carus
Dresden, Saxonia, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden

Responsible Party: Oliver C. Radke, MD, PhD, DEAA, Dpt. of Anesthesia and Intensive Care Medicine, University Hospital, TU Dresden, Germany Identifier: NCT01073917     History of Changes
Other Study ID Numbers: EK375122009
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010

Keywords provided by Technische Universität Dresden:
General Anesthesia
electrical impedance tomography
pressure support
spontaneous breathing
laryngeal mask
Patients who are scheduled for elective knee or ankle surgery

Additional relevant MeSH terms:
Respiratory Aspiration
Pulmonary Atelectasis
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases
Central Nervous System Depressants
Physiological Effects of Drugs