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AtelectasisNCT04712084

Postoperative Lung Collapse Prevention

A study testing Positive pressure in people with Atelectasis, run by Lennart Magnusson.

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

General anaesthesia is known to promote lung collapse (atelectasis) which will persist in the postoperative period. Inflating the lung to a pressure of 40 cmH2O, called a vital capacity manoeuvre (VCM), performed a few minutes before extubation followed by the use of 40% of O2 will prevent postoperative atelectasis… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Atelectasis
What is being tested?
Positive pressure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
3 Jul 2013to 22 Jul 2014
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient undergoing gynaecological laparoscopic surgery under general anesthesia

Who cannot join

  • BMI > 30 kg/m2 or < 17 kg/m2
  • pregnancy; hypoxemic disease
  • Delay between extubation and CT-scan > 20 minutes

About this study

Official title: Postoperative Atelectasis Prevention by Application of PEEP and Pressure Support Ventilation: a Prospective Randomized Controlled Trial

General anaesthesia is known to promote lung collapse (atelectasis) which will persist in the postoperative period. Inflating the lung to a pressure of 40 cmH2O, called a vital capacity manoeuvre (VCM), performed a few minutes before extubation followed by the use of 40% of O2 will prevent postoperative atelectasis formation. This is not the case if VCM is followed by application of 100% of O2. However the use of 100% of O2 before tracheal extubation is still recommended for safety reason. Application of PEEP associated with pressure controlled ventilation before intubation prevents atelectasis formation despite the use of 100% of O2. The goal of our study was to show that performing a VCM 15 minutes before arousal followed by application of PEEP and pressure support ventilation (PSV) before and after tracheal extubation will prevent the recurrence of atelectasis despite the use of 100% of O2.

Materials and Methods With the ethic committee for research on human beings approval, the investigators randomly assigned 16 non-obese patients scheduled for a gynaecological laparoscopic surgery in two groups. At the end of the surgery the investigators performed a VCM (40cmH2O applied for 12 seconds), then O2 was increased to 100% in both groups. In the patients of the study group, a PEEP of 6 cmH2O was applied associated with a PSV of 8 cmH2O. This was continued after the extubation for 3 minutes. The O2 was then decreased to 40% and, when the expired oxygen saturation was < 50%, PEEP and PSV were removed. For the patients in the control group, no positive pressure was applied during spontaneous ventilation (PEEP = 0 and no PSV). The atelectasis were then measured by computed tomographic scanning.

Read the detailed description

This is a prospective double-blinded study with prior informed written consent obtained from all patients.

Study Population Patients aged 18 to 65 years, American Society of Anesthesiologist (ASA) physical status classification I to III, undergoing gynaecological laparoscopic surgery under general anaesthesia were included in this prospective, randomised, double-blinded study.

Exclusion criteria were severe pulmonary disease, body mass index (BMI) more than 30 kg /m2 or less than 17, pregnancy or any other disease for which hypoxemia could be harmful. If the delay between extubation and the computed tomography (CT) scan was over 20 minutes, patients were also excluded.

Study treatments No premedication was given. General anaesthesia was standardized for all patients. Standard monitoring was applied. General anaesthesia was induced intravenously with fentanyl 1 to 2 μg/kg, propofol 2 to 3 mg/kg, and rocuronium 0.6 mg/kg. The airways were secured by endotracheal intubation.

Desflurane was used for maintenance at 1 minimal alveolar concentration (MAC) in 40% oxygen and air. Additional rocuronium was injected in order to maintain a train-of-four ratio (TOF ratio) between 0 and 1/4. Supplemental fentanyl was administered in order to maintain blood pressure and/or heart rate values within a range of 20% compared to baseline values.

For ventilation, the investigators used pressure controlled mode with tidal volume guaranteed (pressure controlled - guaranteed volume, General Electrics Datex-Ohmeda Aisys®). The settings of ventilation were, tidal volume 6-8 ml/kg (ideal body weight), frequency 10 - 20 per min. (expired CO2 5.3 - 5.8 kPa), PEEP of 6 cmH2O and I:E ratio 1:2.

Fifteen minutes before the end of the surgery, a VCM (40cmH2O applied for 12 seconds) was performed, then O2 was increased to 100% in both groups. Sugamadex (4 mg/kg if TOF <2/4, 2 mg/kg if TOF >2/4) was administered in order to reverse neuromuscular block. General anaesthesia was continued until TOF ratio > 90%.

Randomization was performed when spontaneous ventilation resumed. In the study group, inspiratory support of 8 cmH2O was applied associated with PEEP at 6 cmH2O. After extubation, same support was applied by facemask for 3 minutes. O2 was then decreased to 40% and, when the expired oxygen fraction was < 50%, PEEP and PSV were switched off.

In the control group, no positive pressure and no PEEP were applied during spontaneous ventilation and 100% of O2 was applied for 3 minutes after extubation with a facemask.

Patients were then transported to the CT scan breathing 40% of O2 via a facemask. The peripheral oxygen saturation was continuously monitored by pulse oximetry. Postoperative pain management consisted of the residual effect of intraoperative fentanyl and paracetamol if required.

Measurements Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity).

Measurement was performed for all the lung and the lungs were also divided in 3 zones (upper, middle and lower). Each right and left lung surfaces were extracted and a window setting of -1000 to +100 Hounsfield Units (HU) was selected to assess the total lung surface. A threshold of -1000 to -500 HU was applied to quantify the amount of normally ventilated lung, a second threshold of -500 to -100 HU was chosen to establish the surface of poorly ventilated lung, and a third threshold of -100 to +100 HU was set to measure the surface of atelectatic lung area. The right and left lungs surface were summed and reported to the total lung surface(18).

Study Outcome The primary outcome was diminution of atelectatic and poorly ventilated lung volume in the study group compared to the control group.

Statistical Analysis Values are expressed as mean +/- SD. Baseline results and atelectatic surface were compared by a one-way analysis of variance for continuous variables and with X2 for discrete variables. P < 0.05 was considered significant.

Conditions
Atelectasis
Being tested
Positive pressure
Keywords
anesthesia, general
Medical subject headings
Pulmonary Atelectasis

What participants receive

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

  • Positive pressureProcedure or surgery

    Inspiratory support of 8 cmH2O was applied associated with PEEP at 6 cmH2O. After extubation, same support was applied by facemask for 3 minutes

Study groups in NCT04712084
Study groupRoleWhat they receive
Control groupNo interventionExtubation procedure following standard of care
Pressure support groupExperimentalExtubation procedure is performed with 100% of O2 but with application of positive pressure before and after extubation
Receives: Procedure: Positive pressure

What is being measured

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

  1. Atelectatic surface

    Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity)

    Measured: 10 - 20 minutes after extubation

Timeline

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

  1. First posted15 Jan 2021
  2. Study start3 Jul 2013
  3. Primary completion22 Jul 2014
  4. Study completion22 Jul 2014

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective double-blinded study Randomization was performed when spontaneous ventilation resumed at the end of the surgery
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712084
Sponsor's protocol ID
anesth2020
Status last verified
Feb 2021
First submitted
13 Jan 2021
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Positive pressure in people with Atelectasis, run by Lennart Magnusson.

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 3 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Atelectatic surface (time frame: 10 - 20 minutes after extubation). 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 4 Feb 2021.

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