Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ulm
About this trial
SupAIR is an international, multicenter, randomized controlled trial investigating whether airway management and neuromuscular blockade during general anesthesia influence postoperative pulmonary complications.
Approximately 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms: tracheal intubation with moderate neuromuscular blockade, tracheal intubation with deep neuromuscular blockade, supraglottic airway with moderate neuromuscular blockade, supraglottic airway with deep neuromuscular blockade, or supraglottic airway without neuromuscular blockade.
The primary outcome is the occurrence of postoperative pulmonary complications during the hospital stay. Secondary outcomes include perioperative complications, surgical conditions, recovery, and functional health. Participants will be followed during hospitalization and again approximately six months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Airway management strategy
Procedure/SurgeryFor the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.
Initiation of neuromuscular blockade (NMB)
Procedure/SurgeryFor the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway is investigated.
Deep versus moderate neuromuscular blockade (NMB)
Other interventionDeep or moderate NMB. Muscle relaxants are administered according to group allocation. Repetitive doses of half the ED95s are administered at Train-of-Four (TOF) count ≥ 2 in the moderate group and at post-tetanic count (PTC) ≥ 2 in the deep blockade group.
Treatment groups
6,800 Participants
are divided into 5 treatment groupsGroup A: Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)Active comparator 2 interventions
Group B: Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)Experimental treatment 3 interventions
Group C: Supraglottic Airway Device without Neuromuscular Blockade (SGA/no NMB)Active comparator 1 intervention
Group D: Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB)Active comparator 2 interventions
Group E: Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Occurrence of at least one postoperative pulmonary complication
The primary outcome is a composite endpoint of postoperative pulmonary complications. It is met if a participant experiences at least one predefined postoperative pulmonary complication and their severity is graded according to the Clavien-Dindo-Classification
Time frame
Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlierSecondary outcomes
1
Intraoperative complications
The classification of intraoperative adverse events (ClassIntra), ranging from grade 0 to grade V. It is used to assess intraoperative anaesthesia- and surgery-related complications.
Time frame
During the surgery2
Critical respiratory events in the recovery room
The outcome is met if at least one predefined critical respiratory event occurs. Events include upper airway obstruction requiring intervention, hypoxaemia not responding to active interventions, signs of respiratory distress or impending ventilatory failure, inability to breathe deeply, symptoms of respiratory or upper-airway muscle weakness, suspected pulmonary aspiration, or reintubation.
Time frame
During post-anesthesia care before admission to the normal ward3
Any postoperative in-hospital complication
Postoperative complications are recorded during the hospital stay during predefined visits in accordance with the postoperative morbidity survey including pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound and pain). If a complication occurs each complication is categorized according to the Clavien-Dindo classification.
Time frame
Patients are visited on postoperative days 1 and 3 to 4 in person and on the day of discharge from hospital or day 28 (whatever occurs first) via chart review to document complications between the current and the last assessment.4
Surgical conditions
Surgical conditions will be assessed in a single-blinded manner via the Leiden Surgical Rating Scale which ranges from 1 to 5, with 1 indicating extremely poor surgical conditions and 5 indicating optimal surgical conditions considering visibility, surgical space, muscle contractions, handling tactics and patient movement.
Time frame
During surgery, assessed every 15 minutesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Ulm
Lead sponsor
Medical University of Vienna
Collaborator
Universitätsmedizin Mannheim
Collaborator
Klinikum Oldenburg gGmbH
Collaborator
University Hospital, Zürich
Collaborator
St. Josef Hospital Bochum
Collaborator
Source ClinicalTrials.gov
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