Clinical trial NCT05787717: Parental Presence at Anesthesia Induction
Official title: Parental Presence at Anesthesia Induction in Infants - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Parent-Child Relations
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Parental presence during induction for young infants is still debated. There is a paucity of information on the real-world interaction between parents, infant and the anesthesia team.

Aim To investigate parents' anxiety, need of information and experiences during induction of their infant, as well as staff communication and experiences, using quantitative and qualitative methods.

Methods Randomized controlled trial of parent´s experiences of participating in their infant´s anesthesia induction. Parents will be randomized to being present in the operating room until the infant is asleep due to anesthesia induction (intervention group), or leaving their child to the anesthesia team in the OR holding area (control group).

Detailed description: Background Surgery in a paediatric setting involves a considerable amount of stress for children and for their parents. The pros and cons of parental presence during anesthesia induction are debated, especially in infants. In older children, parents play a critical role in paediatric surgery, since children depend on parents for support and guidance in coping. However, many centers will not allow parental presence for young infants and neonates, since attachment relationships develop during the second half of infancy (6 - 12 months of age), and the risk of complications during induction are increased. However, there is a paucity of information on the real-world interaction between parents, infant and the anesthesia team. Therefore, the present study will investigate how parental presence affects the parents´ perioperative anxiety level and experiences in a randomized controlled trial. Anesthesia team communication, attitudes and experiences and the rate of complications during induction and emergence will also be studied. The study hypothesis is that presence at induction reduces the parents' anxiety level.

Aim To investigate parents' anxiety, need of information and experiences during induction of their infant, as well as staff communication and experiences, using quantitative and qualitative methods.

Methods Design: randomized controlled trial. After informed consent has been obtained from both parents, they are randomized to being present in the operating room until the infant is asleep due to anesthesia induction (intervention group), or leaving their child to the anesthesia team in the Operating Room (OR)holding area (control group).

When they arrive at the OR holding area, the parents are asked to fill in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire. Electrocardiogram (EKG) electrodes are placed on the infant's chest and connected to an anesthesia monitor. Then the infant is transported to the OR together with the parent if in the intervention group. In the intervention group, the parent is encouraged to stay close to their child and are given ample room on one side of the OR table for this purpose. If appropriate, a peripheral i.v. line is placed. A standard pre-induction time-out is performed, after which the anesthesia induction starts (i.v. thiopental or propofol if a line is in place, mask induction with sevoflurane if not). As soon as the child is asleep (no voluntary movements, eyes closed), the parents are escorted out of the OR, and are asked to fill in the APAIS questionnaire a second time. As in the control group, they are informed that they will be called to the Post Anesthesia Care Unit (PACU) at the end of the procedure.

Depending on investigator availability, the parents will be interviewed about their experiences on the day after surgery. In addition, the nurse anesthetist and attending anesthesiologist will be interviewed on the day of surgery.

The induction and the emergence will be video recorded and field notes will be taken by a separate investigator taking care not to disturb the procedure.

Field notes, video-recordings and interviews will be transcribed and analyzed using phenomenological/hermeneutic methods. Open questions about how the subject experienced the induction will be posed, and follow-up questions to obtain in-depth understanding of the subjects' sentiments and reflections.

Eligibility criteria: Inclusion Criteria:

* Infant scheduled for general anesthesia
* parents are available, accompanying their infant

Exclusion Criteria:

* age of infant \> 6 months
* critical illness (supplementary oxygen, inotropic support or ventilator therapy)

Primary outcomes:
measure: APAIS Anxiety
timeFrame: Within 5 minutes of leaving their child to the anesthesia team.
Secondary outcomes:
measure: Infant´s heart rate
timeFrame: From when EKG monitoring starts in the holding area until child is unresponsive due to general anesthesia - a time fram of up to 15 minutes
measure: Adverse events
timeFrame: Anesthesia induction (a time frame of up to 10 minutes)
measure: Staff interview data
timeFrame: Within 24 hours after the case is finished in the OR
measure: Parental interview data
timeFrame: Within 48 hours after the case is finished in the OR
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppsala County
Study officials:
References:
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citation: Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.