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AtelectasisSBAFGANCT01073917

Effects of Spontaneous Breathing Activity on Atelectasis Formation During General Anaesthesia

A study testing Spontaneous Breathing and Pressure Support Ventilation in people with Atelectasis, run by Technische Universität Dresden at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atelectasis
What is being tested?
Spontaneous Breathing and Pressure Support Ventilation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
Mar 2010to Oct 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University Hospital Carl-Gustav-Carus

    Dresden, Saxony, 01307

Other trials in Germany

About this study

Official title: Effects of Spontaneous Breathing Activity on Atelectasis Formation During General Anaesthesia: A Randomized Clinical Trial

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

Read the 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.

Conditions
Atelectasis
Being tested
Spontaneous Breathing, Pressure Controlled Ventilation, Pressure Support Ventilation
Keywords
Ventilation, General Anesthesia, electrical impedance tomography, pressure support, spontaneous breathing, laryngeal mask, Patients who are scheduled for elective knee or ankle surgery
Medical subject headings
Pulmonary Atelectasis, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spontaneous BreathingOther

  • Pressure Controlled VentilationOther

  • Pressure Support VentilationOther

Study groups in NCT01073917
Study groupRoleWhat they receive
Spontaneous BreathingOtherPatients will be breathing spontaneously during anesthesia
Receives: Other: Spontaneous Breathing
Pressure controlled ventilationOtherPatients 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).
Receives: Other: Pressure Controlled Ventilation
Pressure Support VentilationOtherThe 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.
Receives: Other: Pressure Support Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regional ventilation at the end of anaesthesia and at discharge from PACU compared to baseline values obtained before induction

    Measured: Before, during and after anesthesia

Secondary outcomes (1)
  1. Differences in spirometry values, oxygenation in the PACU (measured as SpO2 at room air), breathing effort

    Measured: Before, during and after anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073917
Sponsor's protocol ID
EK375122009
Acronym
SBAFGA
Status last verified
Oct 2010
First submitted
22 Feb 2010
Last updated
29 Oct 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Spontaneous Breathing and Pressure Support Ventilation in people with Atelectasis, run by Technische Universität Dresden at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010.

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