Parental Presence at Anesthesia Induction

Anesthesia Clinical Trial

— PPAI  

Official title:

Parental Presence at Anesthesia Induction in Infants - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787717
• Other study ID #: PPAI1
• Status: Completed
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: May 8, 2024

Study information

• Verified date: May 2024
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 8, 2024
• Est. primary completion date: May 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Parent-Child Relations

Intervention

Other:
• Parental presence
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

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala	Uppsala County

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. Erratum In: Lancet Respir Med. 2017 May;5(5):e19. Lancet Respir Med. 2017 Jun;5(6):e22. — View Citation

Landier M, Villemagne T, Le Touze A, Braik K, Meignan P, Cook AR, Morel B, Lardy H, Binet A. The position of a written document in preoperative information for pediatric surgery: A randomized controlled trial on parental anxiety, knowledge, and satisfaction. J Pediatr Surg. 2018 Mar;53(3):375-380. doi: 10.1016/j.jpedsurg.2017.04.009. Epub 2017 Apr 21. — View Citation

Landolt MA, Boehler U, Schwager C, Schallberger U, Nuessli R. Post-traumatic stress disorder in paediatric patients and their parents: an exploratory study. J Paediatr Child Health. 1998 Dec;34(6):539-43. doi: 10.1046/j.1440-1754.1998.00303.x. — View Citation

Malik F, Marwaha R. Developmental Stages of Social Emotional Development in Children. 2022 Sep 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK534819/ — View Citation

Piira T, Sugiura T, Champion GD, Donnelly N, Cole AS. The role of parental presence in the context of children's medical procedures: a systematic review. Child Care Health Dev. 2005 Mar;31(2):233-43. doi: 10.1111/j.1365-2214.2004.00466.x. — View Citation

Scrimin S, Haynes M, Altoe G, Bornstein MH, Axia G. Anxiety and stress in mothers and fathers in the 24 h after their child's surgery. Child Care Health Dev. 2009 Mar;35(2):227-33. doi: 10.1111/j.1365-2214.2008.00920.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	APAIS Anxiety	Parents fill out the form Amsterdam Preoperative Anxiety and Information Scale. The Anxiety component of the scale har four items and the total score (minimum value 4, max 20) is the primary outcome. High scores indicate worse outcome.	Within 5 minutes of leaving their child to the anesthesia team.
Secondary	Infant´s heart rate	The changes in heart rate of the infant during the pre-induction period and during induction.	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
Secondary	Adverse events	Adverse events during induction such as desaturation, bradycardia, hypotension, difficult intubation, difficult i.v. access.	Anesthesia induction (a time frame of up to 10 minutes)
Secondary	Staff interview data	The staff self-reported experience of parental presence at induction (interview data)	Within 24 hours after the case is finished in the OR
Secondary	Parental interview data	The parents self-reported experience of leaving their child before surgery (interview data)	Within 48 hours after the case is finished in the OR