AtelectasisNCT01749436
Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery
An observational study of Atelectasis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
General anesthesia results in the development of atelectasis in the dependent areas of the lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures, pneumoperitoneum increases already present atelectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- What is being tested?
- Lung ultrasound imaging examinations
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Sep 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for laparoscopic surgery
Who may be able to join
- Patients aged 18 years and older
- Scheduled for laparoscopic surgery
- Physical status 1-3
Who cannot join
- Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
- Contraindication to the placement of an arterial line
- Very severe chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
General anesthesia results in the development of atelectasis in the dependent areas of the lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures, pneumoperitoneum increases already present atelectasis.
Several methods have been suggested to reduce the impact of atelectasis during surgery. However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.
Read more
This observational study will aim to clarify the role of lung ultrasound imaging during laparoscopic surgery for the diagnostic and monitoring of atelectasis.
This study is designed to:
- Demonstrate a link between the lung ultrasound aeration score, the partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the oxygenation index.
- In the event of intraoperative desaturation, study the impact of positive end-expiratory pressure (PEEP) and/or increase of FiO2 on the aeration score.
- Study the impact of pain on diaphragmatic function and the aeration score.
Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia and changes occurring during the stay in the recovery room.
Read the detailed description
On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination.
The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring.
Lung ultrasound examinations will be performed 5 minutes following induction of general anesthesia and 5 minutes after insufflation of the abdomen with carbon dioxide. In the event of a desaturation needing an intervention (increase of FiO2 or PEEP), ultrasound imaging will be repeated before and after the intervention. Presence of a pneumothorax or endobronchial intubation will be assessed during each examination. Fifteen minutes after arrival and immediately before discharge from the recovery room, lung ultrasound examinations will also be performed.
FiO2 and vital signs will be recorded at each ultrasound examination. Arterial blood samples will be collected simultaneously. Pain rating using the visual analog scale and diaphragmatic function will be assessed during the preoperative ultrasound examination and before discharge from the recovery room.
- Conditions
- Atelectasis
- Being tested
- Lung ultrasound imaging examinations
- Keywords
- Atelectasis, Pneumoperitoneum, Hypoxemia
- Medical subject headings
- Pulmonary Atelectasis, Pneumoperitoneum, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound imaging examinationsOther
Lung ultrasound examinations performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis related to laparoscopic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasound imaging | Lung ultrasound imaging examinations performed during the perioperative period for the monitoring of atelectasis associated with laparoscopic surgery Receives: Other: Lung ultrasound imaging examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung aeration
Estimate lung aeration by ultrasound imaging using a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation)
Measured: From arrival in the operating theatre to immediately before discharge from the recovery room (Day 0)
Secondary outcomes (4)
Gas exchange
Assess the impact of the different stages of anesthesia and surgery on gas exchange by measuring arterial blood gases.
Measured: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Diaphragmatic function
Assess diaphragmatic function by ultrasound imaging
Measured: On arrival in the operating theatre and immediately before discharge from the recovery room (Day 0)
Incidence of pneumothorax
Estimate the incidence of pneumothorax by ultrasound imaging
Measured: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Incidence of endobronchial intubation
Estimate the incidence endobronchial intubation by ultrasound imaging
Measured: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Martin Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749436
- Sponsor's protocol ID
- MG2012-001
- Status last verified
- Sep 2013
- First submitted
- 12 Dec 2012
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01749436
- Acronym / sponsor ID
- MG2012-001
- Conditions
- Atelectasis
- Keywords
- Atelectasis, Pneumoperitoneum, Hypoxemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
General anesthesia results in the development of atelectasis in the dependent areas of the lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures, pneumoperitoneum increases already present atelectasis.
Several methods have been suggested to reduce the impact of atelectasis during surgery. However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.
This observational study will aim to clarify the role of lung ultrasound imaging during laparoscopic surgery for the diagnostic and monitoring of atelectasis.
This study is designed to:
- Demonstrate a link between the lung ultrasound aeration score, the partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the oxygenation index.
- In the event of intraoperative desaturation, study the impact of positive end-expiratory pressure (PEEP) and/or increase of FiO2 on the aeration score.
- Study the impact of pain on diaphragmatic function and the aeration score.
Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia and changes occurring during the stay in the recovery room.
Detailed description
On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination.
The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring.
Lung ultrasound examinations will be performed 5 minutes following induction of general anesthesia and 5 minutes after insufflation of the abdomen with carbon dioxide. In the event of a desaturation needing an intervention (increase of FiO2 or PEEP), ultrasound imaging will be repeated before and after the intervention. Presence of a pneumothorax or endobronchial intubation will be assessed during each examination. Fifteen minutes after arrival and immediately before discharge from the recovery room, lung ultrasound examinations will also be performed.
FiO2 and vital signs will be recorded at each ultrasound examination. Arterial blood samples will be collected simultaneously. Pain rating using the visual analog scale and diaphragmatic function will be assessed during the preoperative ultrasound examination and before discharge from the recovery room.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasound imaging | – | Other: Lung ultrasound imaging examinationsLung ultrasound imaging examinations performed during the perioperative period for the monitoring of atelectasis associated with laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for laparoscopic surgery
Key inclusion criteria (3 listed)
- Patients aged 18 years and older
- Scheduled for laparoscopic surgery
- Physical status 1-3
Key exclusion criteria (3 listed)
- Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
- Contraindication to the placement of an arterial line
- Very severe chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasound imaging examinationsLung ultrasound examinations performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis related to laparoscopic procedures. | Other | Lung ultrasound imaging |
Primary outcome
Lung aeration
Time frame: From arrival in the operating theatre to immediately before discharge from the recovery room (Day 0)
Estimate lung aeration by ultrasound imaging using a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation)
4 secondary outcomes
Gas exchange
Time frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Diaphragmatic function
Time frame: On arrival in the operating theatre and immediately before discharge from the recovery room (Day 0)
Incidence of pneumothorax
Time frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Incidence of endobronchial intubation
Time frame: From 5 minutes following induction of anesthesia to immediately before discharge from the recovery room (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 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 16 Sep 2013. 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 Canada. 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?
Lung aeration (time frame: From arrival in the operating theatre to immediately before discharge from the recovery room (Day 0)). 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 16 Sep 2013.