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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01073917
First received: February 22, 2010
Last updated: October 28, 2010
Last verified: October 2010
  Purpose

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 Intervention
Atelectasis
Other: Spontaneous Breathing
Other: Pressure Controlled Ventilation
Other: Pressure Support Ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effects of Spontaneous Breathing Activity on Atelectasis Formation During General Anaesthesia: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in spirometry values, oxygenation in the PACU (measured as SpO2 at room air), breathing effort [ Time Frame: Before, during and after anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01073917

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

Additional Information:
No publications provided

Responsible Party: Oliver C. Radke, MD, PhD, DEAA, Dpt. of Anesthesia and Intensive Care Medicine, University Hospital, TU Dresden, Germany
ClinicalTrials.gov Identifier: NCT01073917     History of Changes
Other Study ID Numbers: EK375122009
Study First Received: February 22, 2010
Last Updated: October 28, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Ventilation
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:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014