- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02055807
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Postoperative pulmonary complications contribute to the morbidity of surgical patients. During general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. The adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. Despite the use of similar mechanical ventilation strategies, two recent studies (IMPROVE, PROVHILO) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. In these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results.
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. Ventilator settings will be adjusted according to randomization.
A second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. In the PEEP group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. A lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia.
Fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. Fraction of inspired oxygen (FiO2) and vital signs will be recorded during each ultrasound examination. Arterial blood samples will be collected simultaneously. The aeration score will be calculated for each lung ultrasound examination.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Centre hospitalier de l'Université de Montréal (CHUM)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients aged 18 years and older
- Scheduled for surgery by laparotomy (expected to last at least 2 hours)
- American Society of Anesthesiologists classification: physical status 1-3
Exclusion Criteria:
- Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
- Contraindication to the placement of an arterial line
- Very severe chronic obstructive pulmonary disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: PEEP and recruitment maneuvers
A PEEP of 7 cm H2O will be applied starting after intubation until the end of surgery.
Recruitment maneuvers (continuous positive pressure of 30 cm H20 for 30 seconds) will be initiated following intubation and repeated every 30 minutes during surgery and immediately prior to extubation.
Lung ultrasound examinations will be 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.
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Aktiv komparator: ZEEP (Zero end-expiratory pressure)
No PEEP nor recruitment maneuvers will be used during surgery.
Lung ultrasound examinations will be 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Lung aeration
Tidsramme: Post-induction to pre-emergence of anesthesia - Day 0
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Compare lung aeration between two different mechanical ventilation strategies (with or without PEEP and recruitment maneuvers) using ultrasound imaging and a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).
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Post-induction to pre-emergence of anesthesia - Day 0
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Re-aeration following recruitment maneuvers
Tidsramme: Prior and after the first recruitment maneuver during general anesthesia - Day 0
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Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).
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Prior and after the first recruitment maneuver during general anesthesia - Day 0
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Atelectasis secondary to induction
Tidsramme: Lung aeration score prior and after intubation - Day 0
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Estimate development of atelectasis secondary to intubation.
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Lung aeration score prior and after intubation - Day 0
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Atelectasis secondary to extubation
Tidsramme: Lung aeration score prior and after extubation - Day 0
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Estimate development of atelectasis secondary to extubation.
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Lung aeration score prior and after extubation - Day 0
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13.293
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